Lancaster City Council
October 14, 2025

Proposal: Accelerated Transcranial Magnetic Stimulation (TMS) for Treatment of Methamphetamine-Related Substance Use Disorder – A Pilot Program Proposal Bid for RFP# 865-26 Drug Treatment Program 12 September 2025 Proposers: Mark Liker MD – Principal Investigator John Whalen PhD – Co-Investigator Thomas Deuel MD PhD – Co-Investigator Brainstim Centers Inc. 28212 Kelly Johnson Pkwy Suite 215 Valencia CA 91355 www.brainstimcenters.com

1. Proposal Summary. 1.1 Clinical Unmet Need – Effective Treatment of Substance Use Disorder Related to Methamphetamine. Substance Use Disorder related to methamphetamine (SUD-M) is a significant social and economic challenge to Lancaster City and many other cities around the country. Over 32,500 psychostimulant overdose deaths were reported in 2021 in the United States [1], the majority involving methamphetamine. Individuals with SUD-M face severe psychiatric comorbidities, cognitive impairments, and extremely high relapse rates. Importantly, no FDA-approved pharmacological treatments exist for SUD-M, creating an urgent need for innovative, non-pharmacological therapies. 1.2 TMS – An Emerging Therapy for Treating Addiction. Transcranial Magnetic Stimulation (TMS) is a non-invasive (i.e. no surgery) neuromodulation technique that uses magnetic pulses to modulate cortical excitability and network connectivity. TMS is FDA-approved for treatment-resistant Major Depressive Disorder (MDD), obsessive-compulsive disorder (OCD), and smoking cessation [2,3]. TMS delivers repetitive magnetic pulses to targeted regions of the cerebral cortex, modulating neuronal activity and synaptic plasticity, and clinical evidence has supported its effectiveness in circuits implicated in mood regulation and addiction. Beyond FDA-approved uses, a growing body of literature has explored off-label applications of TMS, particularly in the treatment of Substance Use Disorders (SUDs) such as methamphetamine, cocaine, nicotine, and alcohol dependence [4]. Several clinical studies investigating TMS for SUDs have demonstrated promising results in reducing drug craving, improving executive function, and modulating reward-related brain networks, across various substances [5]. 1.3 Project Objectives. Brainstim Centers Inc. proposes a pilot treatment program to treat methamphetamine-related Substance Use Disorder (SUD-M) with TMS to reduce cravings and other symptoms. TMS has been reported as effective in treating SUD-M symptoms in 38 different published research studies but has not been FDA-approved yet for SUD-M treatment [4]. Led by a team of neuroscience-trained clinicians and engineers, Brainstim Centers Inc. leverages latest advances in neuroscience (e.g. neuroimaging, biometrics, Artificial intelligence and TMS technology developments) to treat a number of on-label and off-label conditions. The primary objective of this study is to demonstrate that an accelerated program of TMS (5-day treatment program vs a traditional 6-week treatment program) can effectively treat SUD-M. If successful, a secondary objective is to review clinical data to identify potential biometric evidence in qEEG and MRI data that can be used to objectively monitor SUD-M symptom improvements. An additional secondary objective is to compile preliminary evidence to support additional expanded TMS treatment for SUD-M programs/studies. A complete list of secondary objectives are listed in the Work Plan Data Analysis section (Section 4.2.6 Data Analysis). While Brainstim Centers Inc., as a treatment clinic, cannot pursue FDA-approval for a new indication for TMS for SUD-M, the center would potentially partner with any of the TMS manufacturers to conduct follow-up studies to support a new indication for treating SUD-M with TMS. 1.4 Approach. Brainstim Centers Inc. proposes an IRB-approved pilot treatment program to provide TMS treatment and collect related biometric and assessment data from 15 participants that have been diagnosed with SUD-related to methamphetamine use and that are seeking treatment. Through a partnership with the Tarzana Treatment Center of Lancaster CA, Brainstim Centers Inc. will identify and recruit study participants interested in participating, and that meet all eligibility criteria. Interested candidates will be consented, screened, and if eligible, baseline measures will begin the same day. The study itself consists of three phases. In Phase I, participants will be asked to complete a number of questionnaire assessments to characterize their SUD condition as well as identify the types and severities of their symptoms. Participants will have two biometric measures taken – an electro-encephalograph (qEEG) recording of brain waves, and an MRI image scan. The former will be used to establish brainwave pattern activity at baseline. The latter will be used to map brain anatomy and measure certain brain activities. In Phase II, participants will begin a 5-day course of accelerated TMS treatments. This consists of 10x 15-minute TMS treatment sessions, with 45-minute rest periods in between, for 5 days. Participants will typically start treatments at 8am and complete their treatment course by 6:30pm. Meals and rest areas will be provided to each participant between each 15-minute session. At the end of the week of treatment, participants will be asked to complete another series of questionnaire assessments to check their symptoms. Phase III of the study is a 3-week period during which the participant will be asked to come to Brainstim Centers 1x per week to receive a single maintenance TMS treatment (15 minutes) and asked to complete the same series of questionnaire assessments. At the end of the study (4 weeks from the start of treatment), participants will be asked to participate in an exit interview. All data collected from the study will be used to characterize the efficacy of TMS on treating patient symptomology.

Figure 1.1 Gantt chart /flow chart of the major tasks which each program participant will need to complete. Potential candidates will first be pre-screened by the treatment center for potential eligibility. Those candidates will be invited to visit Brainstim Centers for screening and consenting. Once enrolled, participants will have baseline MRI scans and a TMS threshold mapping study will be performed to prepare for treatment. Participants will then undergo a 5-day accelerated TMS treatment program followed by 3 weeks of one-day TMS maintenance visits. questionnaire assessments and qEEGs will also be collected at baseline and weekly to measure any changes to symptoms. 1.5 Deliverables. Over the course of this program, Brainstim Centers will provide monthly progress reports to the city. This will include interim study census counts (e.g. numbers recruited, numbers enrolled, numbers completing phases), and where appropriate, any interim updates on data and early findings. Reports will also include budget spending and invoicing updates. A final report will summarize all key findings, including tests of primary and secondary objectives. The Brainstim Centers team will seek to publish any key findings that may benefit the greater community. Draft versions of any manuscripts or other public releases of program information will be provided to the Lancaster City team for review and approval prior to submission, and acknowledgment of the city’s support will be included. 1.6 Impact. If successful, this study will provide at least three major impacts. First, it will provide evidence for an alternative solution to managing the methamphetamine use challenges of Lancaster City. Second, this will provide first-time evidence of an accelerate (5-day) TMS treatment program’s efficacy in treating SUD-M. Third, these findings will provide a foundation for Brainstim Centers to pursue federal funding (NIMH and NIDA) to conduct an expanded program in Lancaster and the greater Southern California region. 1.7 Innovation. This proposed project is innovative in at least three different aspects. First, there is no prescriptive indication (pharmaceutical, biologic or device) for treatment of methamphetamine use disorder. If successful, this would provide additional evidence to potentially pursue a new indication for treating SUD-M with TMS. Second, this is the first known pilot study seeking to treat methamphetamine use disorder with accelerated TMS – a 5-day intensive program which would provide an efficient treatment option that could be adopted in concert with typical 30-60day in-residence treatment programs at SUD treatment centers. Third, this project will be seeking to determine if objective biomarkers of SUD-M may be identifiable in participants biometric data (qEEG and MRIs). If possible, this would help improve patient diagnosis, symptom characterization, and treatment efficacy using a novel, objective dataset vs traditional questionnaire assessments that rely on patients’ subjective responses to questions. 1.8 Rationale. A significant number of studies have been published investigating the use of TMS to treat addiction. TMS has received FDA approval as an aid for smoking cessation, and multiple studies have reported positive outcomes in reducing nicotine dependence. These findings demonstrate the capacity of TMS to target and modulate reward-related neural circuits, highlighting its potential utility in addressing substance use disorders [6]. Although these have not yet led to new indications for treating SUD, a number of papers have been published and reviewed suggesting that TMS may improve symptoms for patients diagnosed with methamphetamine addiction [4], cocaine addiction [10]; and opiate addiction [11]. In parallel with these advances, researchers have also begun to refine TMS delivery strategies by moving beyond single-target stimulation. Dual-target TMS has shown to be both safe and feasible. In a neuroimaging study of individuals with cocaine use disorder, simultaneous stimulation of the dorsolateral prefrontal cortex (DLPFC) and medial prefrontal/frontopolar cortex modulated striatal and limbic circuits involved in addiction, with no adverse effects reported even at 110% of resting motor threshold. These results provide early evidence that multi-target neuromodulation can be applied safely in substance use populations [13]. Building on this safety foundation, the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol has demonstrated that an accelerated schedule of 10 intermittent theta burst stimulation (iTBS) sessions per day over five consecutive days can induce rapid and durable improvements in treatment-resistant depression [7]. Importantly, the SAINT trial also confirmed that this intensive protocol is safe and well tolerated, with adverse effects limited to headaches and fatigue and no increased seizure risk compared with conventional TMS [7].

Brainstim Centers Inc. Contact Sheet Website: www.brainstimcenters.com Lancaster Office Address: 44151 15th W Suite #210 Lancaster CA 93534 Main Office Address: 28212 Kelly Johnson Pkwy Suite #215 Valencia CA 91355 Phone: 310.895.7122 Fax: 866.471.2949 Name Title Team Responsibilities Phone e-mail Liker, Mark CEO Principal Investigator. Clinical 310.895.7122 [email protected] Whalen, Jack Research Director Co-Investigator. Research 310.403.7370 [email protected] Zommick, Jordan Chief Ops Officer Administrative Director 818.474.6076 [email protected] For any clinically related or research related concerns please contact Mark Liker or Jack Whalen. For billing, operations or other administrative concerns, please contact Jordan Zommick.

2. Brainstim Centers Inc. Profile Brainstem Centers Inc. is a private clinic that provides Transcranial Magnetic Stimulation (TMS) therapy services for treatment of a variety of FDA-approved and non-approved indications. Headquartered in Valencia,CA, Brainstim Centers has additional treatment facilities located in Lancaster CA, Calabasas CA, and Quintana Roo, Mexico. The offices are operated by a clinical and administrative team of between 20-30 resources that report to the management team based at the Valencia office. Dr. Mark Liker, President and founder of Brainstim Centers Inc, as well as a board-certified neurosurgeon, oversees clinical decisions and activities. Jordan Zommick serves as the Chief Operations Officer and handles all operational activities including overseeing budget, administrative, marketing and other operational activities. John Whalen PhD, serves as Clinical Research Director for the center, coordinating design, setup and execution of new research programs. Dr. Thomas Deuel MD is a clinical neurologist with experience in neuromodulation research. Leadership meets weekly to review activities at each site and to provide support/guidance when needed. A complete organization chart showing the team’s reporting structure is presented in section 4 as well as discussed in the Exhibit A (Staff & Personnel) document. Founded in 2019, Brainstim Centers has provided TMS treatment services to the greater Southern California region for just over 5 years. The center has received payment from both private and public payers, as well as out-of-pocket patient payments. The organization is actively registered as a small business with the federal government through SAM.gov. Brainstim Centers Inc. And its subcontractors on this project, to its knowledge, in the last five years have (a) not been named nor have been party-to any lawsuit or litigation. And (b) neither Brainstim Centers nor their insurers have been required to pay any claims or settlements in the last 5 years. 3. Brainstim Centers’ Qualifications & Team Qualifications. Since its founding in 2019, Brainstim Centers has provided TMS treatments to patients presenting with any number of neurological disorders for which other treatments have not been effective. Over those years, Brainstim Centers has provided TMS treatments to more than 700 patients for a variety of both on-label and off-label indications, including: depression, anxiety, symptoms associated with tinnitus, post concussive syndrome, fibromyalgia, autism spectrum disorder, dementia, and other neurological conditions. The research team at Brainstim Centers has presented its TMS research findings at research conferences, and in August 2025 received an IRB exemption for its retrospective studies that will permit submission of manuscripts to peer-reviewed journals for publication. The following is a compilation of presentations given by the Brainstim Centers Inc. team at a variety of research conferences. 1. J. Liker et al. “Harnessing Machine Learning For TBI Diagnosis: Insights from DTI Metrics of Grey Matter Regions.” Boston MA, AANS Oral Presentation, April 2025. 2. J.Liker et al. “Transcranial magnetic stimulation for mild traumatic brain injury.” Los Angeles CA, SBMT Oral Presentation, April 2025. 3. J.Liker et al. “Artificial intelligence application to post concussive syndrome diagnosis.” Los Angeles CA, SBMT Oral Presentation, April 2025. 4. J. Liker et al. “Use of Machine Learning to Diagnose Post Concussive Syndrome Using DTI”. Snowmass CO, Winter Clinics, February 2025. 5. J. Liker et al., Transcranial Magnetic Stimulation Improves Post Concussive Syndrome Scores and DTI Metrics for Traumatic Brain Injury, Snowmass CO, Winter Clinics Oral Presentation. February 2025. 6. J. Liker et al., Use of Machine Learning to Diagnose Post Concussive Syndrome Using DTI.” Houston Tx, CNS poster presentation. October 2024. 7. J. Liker et al. “Transcranial Magnetic Stimulation Improves Post Concussive Syndrome Scores and DTI Metrics for Traumatic Brain Injury.” Houston Tx, CNS Oral Presentation, October 2024. 8. J. Liker et al., “TMS Improves Post-Concussive Syndrome Scores for TBI.” San Francisco CA, National Neurotrauma Society, June 2024. 9. J. Liker et al. “TMS improves post-concussive syndrome scores for TBI.” 14th Annual Traumatic Brain Conference. Washington, DC, 2024. 10. J. Liker et al. “AI-powered traumatic brain injury classification.” Neuroinsights: SUNY Downstate Research Day. Brooklyn, NY, 2024. 11. T. Bierling et al. “Improved DTI fractional anisotropy values correlate with improvement in post-concussive syndrome following transcranial magnetic stimulation.” 2024 Winter Clinics for Cranial and Spinal Surgery. Snowmass Village, CO, 2024.

12. Rajapakshe, I., Jimenez-Diaz, L., Bierling, T., Liker, J., Liker, M.A., and Won, D.S. Spectral Changes due to rTMS in Major Depressive Disorder. Presented at the 2024 Biomedical Engineering Society Annual Conference, Baltimore, MD. October 2024. 13. Jimenez-Diaz, L., Rajapakshe, I., Bierling, T., Liker, J., Liker, M.A., Won, D.S. “Interhemispheric Symmetry in the Alpha Peak Before and After rTMS for Major Depressive Disorder” IEEE Engineering in Medicine and Biology Conference. July 2025. 14. W Pasillas et al. “Changes in neural network associations with RTMS for depression.” Accepted, Biomedical Engineering Society Annual Meeting, San Diego, CA. October 2025. 15. D Soriano et al. “Changes in Phase Lag Index Due to Transcranial Magnetic Stimulation in Major Depressive Disorder” To be presented at the Neural Engineering Conference, San Diego, CA. November 2025. Tarzana Treatment Centers, Inc. (Tarzana TC) is a full-service behavioral healthcare organization that provides high quality, cost-effective substance abuse and mental health treatment to adults and youth. Tarzana TC is a non-profit, community-based organization that operates a psychiatric hospital, residential and outpatient alcohol and drug treatment centers and family medical clinics. All facilities are licensed and certified by the State of California and the County of Los Angeles and are accredited by the Joint Commission. Since 1972, Tarzana TC has provided a comprehensive continuum of healthcare services. To provide high quality, integrated healthcare for substance use and mental health disorders and other chronic physical health conditions which improves the quality of life and health of our patients. Tarzana TC has facilities all over the greater southern California region, including: Lancaster, Palmdale, Los Angeles, and Tarzana to name a few. Ken Bachrach, Ph.D. has been Clinical Director of Tarzana Treatment Centers since 1987. He is a licensed clinical psychologist with over 35 years of experience in the assessment and treatment of individuals with mental health and co-occurring substance use disorders and regularly trains addiction and mental health professionals in this area. He helped develop and oversees TTC’s mental health services and its contract with the Los Angeles County Department of Mental Health. Dr. Bachrach oversees the APA-accredited doctoral internship program in Professional Psychology. He coordinates TTC’s clinical research activities and since 2000 has served as the site Principal Investigator for multiple studies as part of the National Institute of Drug Abuse’s (NIDA) Clinical Trials Network (CTN). Duane Carmalt, M.D., is double Board Certified as an Internal Medicine Physician as well as an Infectious Disease Specialist. His extensive medical training started at Johns Hopkins University in Maryland and continued at Duke University School of Medicine in North Carolina. Dr. Carmalt went on to complete his internship at the University of Oklahoma Hospitals before moving west to fulfill his residency at the Veterans Administration Wadsworth –UCLA Affiliated Hospitals, in Los Angeles, CA. Dr. Carmalt has served patients in the capacity of Emergency Physician, Director of Emergency Department, Medical Director, Medical Consultant and Staff Physician at well-known hospitals and medical centers including Encino Hospital, Tarzana Psychiatric Hospital and the Medical Center of Tarzana. 4. Work Plan 4.1 Project Overview – Major Tasks. Brainstim Centers Inc. proposes a pilot-TMS for SUD-M treatment program to provide TMS treatment services to the greater Lancaster City community to address substance use disorder in the region. The study itself will seek to provide complete TMS treatment for at least 15 enrolled participants. The Gantt chart below (Fig. 4.1) provides a flow chart listing the major tasks to be completed. The project will begin with Brainstim Centers submitting the treatment program protocol to an IRB (WCG Clinical) for review and approval (approximately 4 weeks to complete). In parallel to the IRB review, Brainstim Centers will begin training the internal research team and external partners on the program protocol steps and SOPs. Once the protocol receives IRB approval, the treatment center partners will be contacted to start recruitment. Recruitment will continue for approximately 5 months, with the goal of recruiting 1-2 candidates per week, and enrolling (i.e. successful screening) at least one participant for TMS treatment per week.

Fig 4.1. Gantt chart of the major tasks associated with this TMS treatment program. Seven (7) major efforts will be driven beginning with submission of the program protocol to an IRB for review and approval, as well as initiation of team training and preparation for the study. Recruitment will begin once IRB approval is received, with the goal of recruiting 1-2 candidates per week, and enrolling at least 1 participant per week. With a 4-week study window for each participant, and anticipating some dropouts, the study anticipates completing the treatment portion in approximately 6 months with an additional month needed to complete data analysis and summary reporting.

The proposed TMS treatment program’s details are described in the clinical study protocol that will be submitted to the Investigational Review Board (IRB) for review and approval (commercial IRB: http://www.wcgclinical.com). Brainstim Centers will begin the study with only one participant per week, but may increase enrollment to two or more per week, once the protocol procedures have been refined. With most clinical studies, there is some patient loss to follow-up and/or withdrawal of consent. For this reason, we are scheduling the need to potentially enroll as many as 20 participants, anticipating as many as 5 may be lost. We will only begin enrolling additional subjects (1) if we encounter participant loss, and (2) there is still time to complete the program in the allotted window (Fig. 4.2).

Fig 4.2 Projected schedule for all participant follow ups, assuming one patient enrolled per week. If the first 15 enrolled participants complete the study as planned, all study data should be collected by week 19. If there is participant loss to follow-up (i.e. dropouts), we anticipate the study taking up to 24-weeks. 4.2 Project Overview – Significant Sub Tasks. The following provides additional details on critical subtasks that will be performed for this study. 4.2.1 Candidate Recruitment & Enrollment. A 3-part screening process will be performed to identify program participants: a pre-screening by Tarzana Treatment Center staff followed by 2-days of screening with the Brainstim Centers research team. 4.2.1.1 Pre-Screening by Treatment Facility. Team members at the Tarzana Treatment Center will be provided a pre-screening checklist to help the Brainstim Centers team identify potential study participants. Brainstim Centers would like to prescreen to confirm: methamphetamine related addiction, exclude certain comorbidities (see below); exclude individuals with metallic implants that could effect MR imaging resolution, clarity, or successful image completion; no history of violence or psychoses that could expose the patient themselves, or the research team, to any significant risks. The screening criteria are the following: Inclusion Criteria: 1. Participant is between 18–72 years old. 2. Participant has been diagnosed with a substance use disorder (SUD) by a trained professional related to stimulants (e.g., methamphetamines, cocaine/cocaine derivatives). 3. Participant has used substances on 20 or more days in the last 90 days. 4. The subject and research team agree that high-quality DTI-MRI brain images can be obtained (i.e., no contraindications such as restlessness, metallic implants, or claustrophobia). 1. Participant is willing to comply with all study procedures and remain available for the duration of the study. 2. Participant has been admitted to a substance use disorder treatment clinic for in-patient treatment (boarded). 3. Participant has reliable transportation and is able to attend daily appointments Monday–Friday for 1 full week, followed by 1 visit per week for 3 consecutive weeks. Note: All Inclusion Criteria must be answered YES, to be included in study.

Exclusion Criteria: 1. Participant has been diagnosed with a substance use disorder (SUD) associated only with non-stimulant substances (e.g., alcohol, hallucinogens, or opiates without stimulant use). 2. Participant has been diagnosed with a methamphetamine use disorder (MUD) in combination with alcohol use disorder, where the alcohol use led to prior withdrawal seizures or delirium tremens (DTs). 1. Participant lacks reliable, consistent transportation to attend study appointments. 2. Participant is unable, for any reason, to attend the daily, in-person appointments required by the treatment schedule. 3. Participant has MRI-related contraindications, including unsafe metal implants/devices or claustrophobia. 4. Participant has been diagnosed with a seizure disorder or any systemic illness affecting brain function within the past 5 years. 5. Participant has clinical evidence of stroke or another major neurological disorder that may interfere with adherence and/or safety. 6. Participant has an active substance use disorder that, in the opinion of the investigators, would interfere with adherence and/or safety. 7. Participant has any major medical condition that has not been stable for at least 4 months prior to enrollment. These may include clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disease; cancer; or cardiovascular disease. a. cardiac surgery or myocardial infarction within the last 4 weeks; b. unstable angina; c. acute decompensated congestive heart failure or class IV heart failures; d. current significant cardiac arrhythmia or conduction disturbance particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope; e. Uncontrolled high blood pressure 8. Participant has a history of other major psychiatric disorders (e.g., schizophrenia) or currently has clinically significant, unstable medical comorbidities that, in the opinion of the investigators, would interfere with study compliance and/or safety. 9. Participant has currently (from screening through study participation) expressed homicidal, suicidal, or self-harm ideation. 10. Participant has currently (from screening through study participation) unstable psychotic or manic symptoms not attributable to SUD. 11. Participant has any other condition or issue that, in the opinion of the principal investigator or research team, might significantly impact completion of the study. 12. Participant has conditions that preclude informed consent (e.g., acute psychosis, significant cognitive deficits, mania) or understanding of assessments or program content. 13. Participant is unable to complete study assessments for any reason (e.g., severe cognitive impairment). 14. Participant has initiated a new psychotropic medication (e.g., SSRIs) or experienced a significant change in the dose/prescription of a psychotropic medication within 6 weeks prior to enrollment. 15. Participant experiences a substance use relapse during the study. 16. Participant shows evidence of structural brain injury on neuroimaging. Note, all Exclusion Criteria must be answered NO, to be included in study. Exceptions may be made on review, discussion and permission by the research leadership team, with a good justification. 4.2.1.2 Eligibility Screening by Brainstim Team. Candidates that meet the prescreening criteria will be invited to an in-person Screening Visit 1 at Brainstim Centers. The study will be explained to the candidate, what the potential benefits and risks are, and what expectations the research team will have for the participant. If interested in participating, an eligibility screening checklist (see Pre-Screening above) will be formally reviewed and recorded for the participant’s record. If eligible, the patient will then be consented. 4.2.1.3 Informed Consent Document Review and Signing. Each candidate for program participation will be required to sign an IRB-approved Informed Consent Document (ICD) prior to participating in the study. The ICD will review the overall design of the study, e.g. what the TMS treatment involves, what type of information will be collected from the participants, what types of time commitments will be required, what constraints (time commitments, appointment attendance, etc.) will be required of them; potential benefits of the program; and potential risks of the program. Prior to signing, candidates will be given the opportunity to ask any questions about the study. At any point in time during the course of the treatment program, the participants may withdraw consent on their own will, and they will be withdrawn from the study.

4.2.2 Baseline Data Collection. A variety of datasets will be collected from study participants at baseline to assess their condition prior to the start of TMS treatment. The following summarizes each of the datasets collected. 4.2.2.1 Questionnaire Assessments for Characterizing SUD. Five assessments will be administered to participants at baseline, at the end of week 1 and at the end of the study. • The Generalized Anxiety Disorder 7-item (GAD-7) o A validated 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms, including nervousness, excessive worry, and restlessness. • The Montgomery–Åsberg Depression Rating Scale (MADRS) o A validated, clinician-administered instrument designed to measure the severity of depressive symptoms and track changes over time, particularly in response to treatment. • Patient Health Questionnaire-9 (PHQ-9) o A validated 9-item self-report tool used to screen for, diagnose, and monitor the severity of depressive symptoms. • Visual Analog Scale for Cravings o A validated self-report measure consisting of a 10-cm (0–100 mm) line anchored by “no symptom” and “worst imaginable symptom,” used to quantify and monitor the current intensity of a single symptom (e.g., pain, anxiety, craving), with the score measured as the distance in millimeters from the “no” anchor. • Urge to Use Scale o A validated self-report questionnaire designed to assess the intensity, frequency, and persistence of urges to use substances. Items typically ask participants to rate their level of craving, difficulty resisting use, and thoughts about using. 4.2.2.2 Vitals Measurements. • Heart Rate (HR) and blood pressure (BP) will be measured twice per day during the accelerated TMS week, ones in the morning and once in the afternoon. In weeks 2 through 4, HR and BP will only be taken once at some time during the visit. 4.2.2.3 Quantitative Electro-EncephaloGraphic (qEEG) Brainwave Recording. • qEEG recordings collected from each patient at baseline, at interim time points and at end of treatment will be analyzed to identify different wave patterns (alpha, beta, theta, frequencies and amplitudes) frequency spectrum analysis. 4.2.2.4 MRI Scan. All participants will have three (3) MRI scans performed over the course of the study: 1) at baseline, 2) at the end of the accelerated TMS course week 1; and at the end of study week 4. MRI scans will be performed at Advance Imaging Center in Palmdale using a minimum 3T MRI scanner. Full 3D scans of the brain will be performed, taking less than 20 minutes to complete. Each participant will be asked to bring a copy of their baseline scan back to Brainstim Centers with themselves, to complete TMS threshold mapping (see below). 4.2.2.5 Scalp Surface Mapping and Registration. The session begins with patient setup and registration, using anatomical landmarks including the left ear, nasion, and right ear. A digital pointer is then used to record additional scalp surface points, enhancing registration accuracy. Once the head registration is complete, the system confirms alignment to ensure precise neuronavigation throughout the procedure [8]. 4.2.2.6 Electrode Placement for EMG Recording. Surface electromyography (EMG) electrodes are placed over the target muscle to record motor evoked potentials (MEPs). Common target muscles include the Abductor Pollicis Brevis (APB) and the First Dorsal Interosseous (FDI). A grounding electrode is also applied to ensure signal stability and minimize electrical noise during stimulation [8]. 4.2.2.7 Loading MRI and DTI Data The patient’s structural MRI and diffusion tensor imaging (DTI) data are loaded into the neuronavigation software. The motor cortex “hand knob” region is identified as the initial target. The software overlays the DTI tractography, providing a visualization of corticospinal tract pathways for accurate mapping [8].

4.2.2.8 Motor Mapping Procedure. Transcranial magnetic stimulation is applied to the motor cortex to identify the area that consistently elicits motor-evoked potentials (MEPs) from the target muscle via surface EMG. Stimulation sites are tested until a reproducible MEP is observed, confirming the motor hotspot. The mapping process focuses on producing MEPs within the amplitude range of 150-1000 µV and 15-25 ms [8]. 4.2.2.9 Resting Motor Threshold (RMT) Determination. Once the hotspot is identified, the coil remains in position and stimulation intensity is gradually decreased to determine the resting motor threshold (RMT). RMT is defined as the minimum stimulator output that produces MEPs ≥50 µV in at least 5 out of 10 consecutive trials in a relaxed target muscle. This threshold serves as the baseline for calculating stimulation intensity in subsequent treatment protocols. For this study, stimulation will be delivered at 120% of the RMT, rather than 80%, to achieve a higher electric field strength and ensure sufficient neuronal activation in the target area [8]. 4.2.3 Accelerated TMS Treatment (Week 1). The accelerated TMS treatment protocol consists of receiving 10 TMS treatment sessions per day for 5 consecutive days, totaling 50 sessions. Each TMS session takes approximately 20 minutes, and participants are given 40 minutes afterwards for resting before the next session begins. One day’s program takes approximately 10.5 hours to complete. The TMS treatment includes two stimulation protocols delivered back-to-back during each TMS session. 4.2.3.1 L-DLPFC Protocol 1. The first protocol (intermittent theta burst stimulation or iTBS) targets the left dorsolateral prefrontal cortex (L-DLPFC). The total stimulation time is approximately three minutes. This region is selected based on its role in executive control, decision-making, and the regulation of craving, and its stimulation has demonstrated benefit in prior studies involving substance use disorders and major depressive disorder. Stimulation parameters follow established protocols and consist of bursts of three pulses at 50 Hz delivered at a rate of 5 Hz (one burst every 200 milliseconds), with two seconds of stimulation followed by eight seconds of rest, totaling 600 pulses per session [9]. 4.2.3.2 FPC Protocol 2. The second protocol consists of low-frequency repetitive TMS (rTMS) delivered to the bilateral frontopolar cortex (FPC). Stimulation will be administered at the patient's individualized frequency, determined by baseline qEEG, for a total of 900 pulses per session, lasting approximately 15 minutes. The FPC plays a key role in prospective memory, long-term goal maintenance, and regulation of reward-based behavior, making it a relevant target in efforts to reduce relapse vulnerability in stimulant use disorders. Both regions will be targeted using neuronavigation, with coil positioning guided by each participant’s individual MRI and DTI scans to enhance reproducibility and accuracy [12]. Both stimulation targets are localized with neuronavigation, using each participant’s MRI and diffusion tensor imaging (DTI) data to ensure reproducibility and precision of coil placement. 4.2.4 Maintenance TMS Treatment (Weeks 2-4). Following completion of the initial accelerated TMS treatment week, participants will return for one maintenance treatment session per week for 3 consecutive weeks. Each session will follow the same stimulation protocols used during the accelerated phase. At every maintenance visit, participants will also complete the full battery of self-report and clinician-administered assessments, including the Patient Health Questionnaire-9 (PHQ-9), Montgomery–Åsberg Depression Rating Scale (MADRS), Generalized Anxiety Disorder 7-item (GAD-7), Urge to Use Scale (UTUS), and Visual Analog Scale (VAS). These assessments will allow for continued monitoring of mood, anxiety, craving intensity, and symptom change over the maintenance period. 4.2.5 End of Study. At the end of the TMS Treatments, participants will have a final MRI image scan and qEEG brainwave recording. The research team will conduct a brief exit interview to ask for impression of the study and any issues. 4.2.6 Data Analysis. All data collected from the study will be compiled into the study database and the following analyses will be performed to assess the effect of accelerated TMS against substance use disorder related to methamphetamine uses. This is a small pilot study (n=15), and due to its size cannot be statistically powered, however we will conduct paired t-tests of patients scores at all time points vs baseline to look for any evidence of improvements.

4.2.6.1 Primary and Secondary Objectives. Objectives that will be analyzed for the study are listed below. Objective Type Details Primary Objective Subjects receiving accelerated, TMS show a measurable relative improvement in cumulative symptoms at the end of 4 weeks vs patients receiving current standard of care. Secondary objectives at week 1 After 1-week of accelerated TMS: • Mean cravings are measurably decreased (VAS-Cravings) vs baseline • Mean urge to use is measurably decreased (U2U) vs baseline • Mean anxiety scores (GAD7) vs baseline • Mean depression scores (MADRS) vs baseline • Mean general health (PHQ9) vs baseline • Mean BP is same or lower vs baseline • Mean HR is same or lower vs baseline • Mean weight is same or greater vs baseline. • Mean qEEG wave alpha frequency and amplitude is greater vs baseline Secondary objectives at week 2 After 1-week maintenance TMS: • Mean cravings are measurably decreased (VAS-Cravings) vs baseline • Mean urge to use is measurably decreased (U2U) vs baseline • Mean anxiety scores (GAD7) vs baseline • Mean depression scores (MADRS) vs baseline • Mean general health (PHQ9) vs baseline • Mean BP is same or lower vs baseline • Mean HR is same or lower vs baseline • Mean weight is same or greater vs baseline. Secondary objectives at week 3 After 2-week maintenance TMS: • Mean cravings are measurably decreased (VAS-Cravings) vs baseline • Mean urge to use is measurably decreased (U2U) vs baseline • Mean anxiety scores (GAD7) vs baseline • Mean depression scores (MADRS) vs baseline • Mean general health (PHQ9) vs baseline • Mean BP is same or lower vs baseline • Mean HR is same or lower vs baseline • Mean weight is same or greater vs baseline. Secondary objectives at week 4 After 3-week maintenance TMS: • Mean cravings are measurably decreased (VAS-Cravings) vs baseline • Mean urge to use is measurably decreased (U2U) vs baseline • Mean anxiety scores (GAD7) vs baseline • Mean depression scores (MADRS) vs baseline • Mean general health (PHQ9) vs baseline • Mean BP is same or lower vs baseline • Mean HR is same or lower vs baseline • Mean weight is same or greater vs baseline. • Mean qEEG wave alpha frequency and amplitude is greater vs baseline Participants will be regularly checked for any Adverse Events (AEs) that may occur during the course of the study. The team will investigate and record evidence to determine whether any reports AEs are attributable to the TMS in any way. A complete tabulation of all AEs will be provided as part of the final reports. 4.2.7 Non-Compliance and Loss to Follow-up. The study team will work diligently to minimize participant non-compliance and participant loss-to-follow-up, however there is some risk of occurrence of both in all studies.

Participants who miss an appointment will be given an opportunity to reschedule. If subjects miss more than 2 consecutive appointments, the investigators may opt to withdraw the participant from the study. A missed TMS appointment should be rescheduled ASAP to avoid a loss of continuity of therapy. Participants may also withdraw consent at any time. The investigators may request to conduct an exit interview and to complete assessments to help with study, if the participant is willing. The research team may try to contact any participants who have a non-compliance event to better understand reasons for missed appointments. 4.3 Reporting of Findings. Brainstim Centers will compile data collected as part of this study and provide interim updates to the City. Those interim updates will include study enrollment census at monthly timepoints (screened, enrolled, completed different milestones, etc.), as well as some interim data sets where possible. For example, a composite of baseline findings once all participants have been enrolled in the study; a report on interim findings when all patients complete accelerated TMS; and updates on adverse events that may be reported, if any. 4.4 Addressing City’s Objectives, Work Requirements & Schedule. Brainstim Centers’ “TMS for SUD-M Pilot Program” is a first-of-its kind accelerated TMS treatment program intended to provide an innovative approach to addressing substance use disorder related to methamphetamine use. The purpose of this study is to gather preliminary evidence whether this 4-week TMS treatment program provides an effective and financially feasible approach to addressing the methamphetamine use disorder problem. By measuring symptom severity over the course of the study, this project will help assess whether TMS may help support drug use recovery, reduce recidivism and contribute to long-term public health. This pilot program will help assess the financial feasibility of this program, providing some initial cost estimates for providing accelerated TMS to SUD patients, which can be compared with other treatment costs and also used to assess program scalability. By partnering with the Tarzana Treatment Center, this program will be able to compare study outcomes against long term outcomes of drug treatment patients who have undergone the normal standard of care for methamphetamine use. This program is proposed by a team with experience in neuromodulation, neurorehabilitation and research in novel approaches for neurointervention. 5. Project Staffing Brainstim Centers will staff the project with its own clinical research team. Drs Liker and Whalen have managed and participated in clinical research work as a clinician and a medical product developer, respectively. The Brainstim TMS technicians also have some experience in clinical research work, both in investigator-initiated and industry-sponsored type studies. The TMS technicians at the Lancaster location are experienced in TMS and clinical research. Brainstim Centers will spearhead a team of between 6-12 internal resources on this project, as well as work with experienced clinical researchers at the MR imaging center and at the Tarzana Treatment Center. The co-investigators for this study are Mark Liker MD, Jack Whalen PhD and Thomas Deuel MD. Resumes for each are provided as attachments. Dr. Liker has over 30 years of experience in neuroscience, neurosurgery and neuromodulation. Dr. Whalen has over 20 years of experience in medical product development in the neuromodulation space, as a biomedical engineer. Dr. Deuel has over 20 years experience as a clinical neurologist. The Brainstim Centers Inc. clinical team will engage with clinical case managers at the Tarzana Treatment Center and its Lancaster location. The team at Tarzana have decades of experience in managing substance use disorder cases. Name Title Role in Study Specific Responsibilities on the Project M. Liker MD CEO Principal Investigator. Medical Director. Oversees study providing clinical expertise for study J. Whalen PhD Research Director Co-Investigator Research Director. Oversees management of study activities. T Deuel MD PhD Clinical Neurologist Co-Investigator Clinical screening and medical monitoring of study participants. J Zommick COO Fin. Admin. Management. Oversees budget and operational activities of study. J. Liker MS Researcher Data Analyst Processing all collected research data and analysis C. Vartanyan Researcher Data Researcher Aggregates and analyzes data collected from participants. A. Collis TMS Manager Manager Sets schedule for TMS techs and patients. Supports techs. M. Quezada Senior TMS Tech. Pt. Care and TMS Administer Assessments, qEEG, schedule appts. & perform TMS treatments S. Watson TMS Technician Pt. Care and TMS Perform TMS treatments The following org chart is provided to show how responsibilities are distributed among resources and partners, and also the project’s reporting structure. Brainstim Centers CEO Mark Liker serves as the PI, with Drs Jack Whalen and Thomas Deuel serving as co-investigators. Jordan Zommick will manage all operational and administrative tasks to support the program. Fig 5.1 Organizational chart detailing the various different team members for the project, how they will report to each other, and responsibilities are color coded. 6. Licenses Medical Licensing. Dr. Mark Liker is a practicing neurosurgeon and neurospecialist licensed in the state of California. A copy of Dr. Liker’s license is attached with this application. Business Licenses. Brainstim Centers Inc. Is an S-Corporation registered in the state of California. Any additional licenses or accreditations will be furnished on request.

August 27, 2024
DR. MARK ANDREW LIKER,
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Has Your Mailing Address Changed?California law requires all licensees to report a change of mailing address within 30 days. Y our address of record is publicinformation, available to any consumer, and is displayed onyour DCA Search License Profile. The Board will use theaddress of record to mail wall certificates, renewal notices, and all other official correspondence. If using a post office box(PO Box) for an address of record, you are required by law to provide the Board with a secondary (non-PO Box) mailingaddress, which will be kept confidential. Y ou can update the mailing address associated with your license at any time fromtheDCA BreEZe systemusing the Change of Address option. Additional information regarding changing your mailingaddress can be found on the Board’sAddress of Record / Email Address FAQs webpage. '        '      MARK ANDREW LIKER23929 MCBEAN PKWY STE 215VALENCIA, CA 91355-4468UNITED STATES : ::

A623685/16/19979/30/2026
The Medical Board of California2005 Evergreen Street, Suite 1200 | Sacramento, CA 95815www.mbc.ca.gov | (800) 633-2322 Scan QR Code to View Complete License Profile
BA20231067995
Entity Details
Corporation Name BRAINSTIM CENTERS, INC.

Entity No. 4312062
Formed In CALIFORNIA
Street Address of Principal Office of Corporation
Principal Address 28212 KELLY JOHNSON PARKWAYSTE 215VALENCIA, CA 91355 Mailing Address of Corporation
Mailing Address 28212 KELLY JOHNSON PARKWAY #215VALENCIA, CA 91355 Attention
Street Address of California Office of Corporation
Street Address of California Office 28212 KELLY JOHNSON PARKWAY #215VALENCIA, CA 91355 Officers
Officer Name Officer Address Position(s)
MARK LIKER28212 KELLY JOHNSON PARKWAY #215VALENCIA, CA 91355 Chief Executive Officer, Secretary, Chief Financial Officer Additional Officers
Officer Name Officer Address Position Stated Position
None Entered
Directors
The number of vacancies on Board of Directors is: 0
Director Name Director Address
MARK LIKER 28212 KELLY JOHNSON PARKWAY #215VALENCIA, CA 91355 Agent for Service of Process
Agent Name Mark Liker
Agent Address 28212 KELLY JOHNSON PARKWAY #215VALENCIA, CA 91355 Type of Business
Type of Business Neuro related brainstim medical
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Labor Judgment
No Officer or Director of this Corporation has an outstanding final judgment issued by the Division of Labor Standards Enforcement or a court of law, for which no appeal therefrom is pending, for the violation of any wage order or provision of the Labor Code.

STATE OF CALIFORNIAOffice of the Secretary of StateSTATEMENT OF INFORMATIONCORPORATIONCalifornia Secretary of State 1500 11th Street
Sacramento, California 95814
(916) 653-3516
B1924-8681 07/05/2023 9:57 PM Received by California Secretary of State

For Office Use Only
-FILED-
File No.: BA20231067995
Date Filed: 7/5/2023
Electronic Signature
By signing, I affirm that the information herein is true and correct and that I am authorized by California law to sign.

Mark Liker
Signature
07/05/2023
Date
B1924-8682 07/05/2023 9:57 PM Received by California Secretary of State

7. Sample Curriculum. The following time and events schedule (Fig. 7.1) summarizes the activities/tasks to be completed by each program participant. The program can be broken into three (3) stages: 1) Screening, 2) Accelerated TMS and 3) Maintenance TMS stages.

Screening. Candidates will be prescreened (PS) by the team at the treatment center for potential eligibility. Candidate responses to questions from the American Society of Addiction Medicine (ASAM) assessment will be reviewed to confirm use disorder related to methamphetamine use; assess whether any history of violence or psychosis may preclude participation, and if any medical history or current medical prescriptions may be exclusionary from participating. Candidates which pass through PS will be invited to a screening at Brainstim Centers. At Screening Day 1, the Brainstim Centers research team will explain the study to the candidates, present them with an informed consent document (ICD) and answer any questions they may have regarding the study. If the candidate is willing to participate, they will be asked to sign the ICD and formal screening can begin. Candidates will be screened for medical history that may exclude them from participating and baseline measures will be taken (vitals and questionnaire assessments). Assessments will be used to capture self-reported presence of symptoms related to SUD and the severity of each symptom. A baseline qEEG will be performed, and the candidates will be returned to the treatment center. The research team will review all data collected from Screening Day 1, and if still eligible, the candidates will be asked to return for a second day of screening. On Day 2 Screening, candidates will be transported to a radiology imaging center for baseline MRI imaging. Once completed, patients will return to the Brainstim Centers facility with their MRI scan file, and a TMS threshold mapping will be performed. In total the candidate may spend approximately 4-5 hrs on each screening day to complete all tasks. Week 1 (Accelerated TMS). The schedule for TMS treatment on the accelerated TMS schedule consists of the participant receiving 10 TMS treatment sessions, 1 per hour for 10 hrs total, with each session lasting approximately 15-20 minutes. After each TMS session, participants will be transferred to a “relaxation” room where there will be a lounge chair, a desk and chair, television or other items to relax between sessions. Participants are free to bring their own entertainment (phone, smart device ,etc.) or to do work or reading as well. Participants will be asked to arrive a little before 8am so that TMS sessions can begin at approximately 8am. At the start of each day, participants will be asked if they have any new adverse events to report and/or any changes to their medications. Both will be recorded to their study files. Snacks and lunch options will be provided to each participant on each day. HR and BP measures will be taken in the AM and PM on each day. At the end of the week, participants will be asked to complete another round of questionnaire assessments (the same five assessments taken at baseline). A 1-week qEEG will be recorded sometime at the end of the week. And the participant will be asked to have an MRI taken some time in the following week. Weeks 2-4 (Maintenance TMS). In weeks 2, 3 and 4, participants will be scheduled to report to Brainstim Centers for one 20-minute TMS maintenance treatment. They will be asked to complete the 5 assessments, and vitals (BP, HR) will be measured. Any changes to concomitant medications and/or changes related to adverse events will be documented. On week 4, a final qEEG and MRI scan will be performed and an exit interview will be conducted by the research team for records.

8. Budget / Cost Proposal Total budget cost breakdown for this study. All efforts and costs are proportional to study duration and % effort/usage. Resources for Project Cumulative Per Patient Study PrincipaI Investigator $21,000 $1,400 Study Co-Investigator $21,000 $1,400 Operations Management (budget admin, ops) $21,000 $1,400 TMS Personnel Manager $10,000 $667 Clinical Neurospecialist/Neurol (interview candidates, review assessments) $3,000 $200 Study Coordinator (bookings, appts, scheduling, etc) $18,000 $1,200 TMS Tech 1 (TMS Setup, Operation, etc.) $13,600 $907 TMS Tech 2 (TMS Setup, Operation, etc.) $13,600 $907 TMS Tech 3 (TMS Setup, Operation, etc.), backup $0 $0 Clinical Specialist (Assessments issuance/collection, vitals, data upload to database) $18,000 $1,200 Data Scientist (Processing/analyzing all data collected) $0 $0 Data Scientist (Processing/analyzing DTI data and ML algorithm) $12,000 $800 Clinical Data Review (AEs, Concom Meds, safety review, Pt follow-ups etc.) $12,000 $800 Security Staff $35,000 $2,333 TMS Equipment Costs TMS Chair 1 - Accelerated TMS (6 mo, Pro-rated financing) $25,000 $1,667 Service agreement (6mo. of contract) $9,000 $600 TMS Chair 2 - Maintenance TMS (2nd chair) $12,000 $800 Services/Consultants Costs IRB Registration & maintenance $3,750 $250 Statistician Consultant $10,000 $666 MRI-DTI Data Consultant (IP, DTI Big Data analysis) $10,000 $666 MRI/DTI Scans ($750/pt) $13,500 $900 Study Marketing Costs $2,000 $133 Other Costs Transportation Costs (10 days, $30/day, 20pts) $8,000 $533 Catering Costs $6,000 $400 Reward/Incentive Stipends Costs ($100 complete treatment, $50 per week) - $250 $5,000 $333 Indirect Administrative Costs Rent $22,000 $1,467 Telecom $900 $60 Utilities $3,600 $240 Software Services $7,500 $500 Security, equipment $2,250 $150 Accounting Fees $2,600 $175 Insurance $3,700 $245 Admin Support Staff (remote, HR) $5,000 $333 Totals $350,000 $23,333 Exhibit B Cost Proposal Cost Proposal for project: 15-Patient Study (6-Month Program) Parameter Description Total Number of Participants: 15 Total Program Length: 6 Months Number of Treatment Hours per Week: Week 1: ~25hours/week of TMS treatment Weeks 2-4: <0.5hrs per week of TMS treatment Number of Weeks of Active Treatment: 4 weeks per patient Location(s) of Services: Brainstim Centers Inc. Lancaster Location 44151 15th St W Suite #210 Lancaster CA 93534 Budget: Per participant cost: $23,333 Total participants completing program: X 15 participants Total Program Budget: $350,000.00

9. Exceptions to Agreement Brainstim Centers Inc. has reviewed the PSA including Scope of Services requirements and the insurance policy requirements, and sees no requirements for exceptions to any of the proposed terms. Brainstim Centers Inc. can agree to meet all of the requirements and stipulations in the Scope of Services Exhibit (A). Brainstim Centers Inc. does not currently propose any exceptions to the Professional Services Agreement nor to the Insurance Requirements stipulated in the RFP, except for the Commercial Automobile Liability. Brainstim Centers Inc. does not own or lease any vehicles to perform any of its services, therefore it is proposed that this requirement be excepted from the list of insurance coverage requirements. If awarded this project contract, Brainstim Centers will agree to the terms of the Professional Services Agreement. 9 SIGNATURE SHEET
My signature certifies that the proposal as submitted complies with all terms and conditions as set forth in RFP No. 865-26.

My s i g n a t u r e c e r t i f i e s t h a t t h i s f i r m h a s n o b u s i n e s s o r p e r s o n a l r e l a t i o n s h i p s w i t h a n y o t h e r c o m p a n i e s o r person that could be considered a conflict of interest, or potential conflict of interest to the City of Lancaster, pertaining to any and all work or services to be performed as a result of this request and any resulting Contract with the City.

The Vendor hereby certifies that it has:
• Read each and every clause of this RFP and addenda, including Addendum # ___________. • Included all costs necessary to complete the specified work in its proposed prices. • Agreed that if it is awarded the Contract, it will make no claim against the City based upon misunderstanding of any provision of the Agreement. Should conditions turn out otherwise than anticipated by it, the Vendor agrees to assume all risks incident thereto.

I hereby certify that I am authorized to sign as a Representative for the Firm:

Name of Firm: ___________________________________________________________________________ Address: ___________________________________________________________________________ Fed ID No: ___________________________ DIR # (if applicable): ___________________________ Name (print): ___________________________________________________________________________ Name (sign): ___________________________________________________________________________ Title: _________________________________________________________________________________ Telephone: ___________________________ Fax: _______________________________________ Email: _________________________________ Date: _______________________________________ *To receive consideration for award, this signature sheet must be returned with the Proposal.*

10 California Levine Act Statement
California Government Code Section 84308, commonly referred to as the "Levine Act," prohibits any Lancaster official from participating in any action related to a contract or application if he or she receives any political contributions totaling more than $250 within the previous twelve months, and for twelve months following the date a final decision is rendered.

The Levine Act also requires a Lancaster City official who has received such a contribution to disclose the contribution on the record of the proceeding.

Current Lancaster City Council Members are listed at:
https://www.cityoflancasterca.org/government/city-officials/city-council-copy Current Planning Commissioners are listed at:
https://www.cityoflancasterca.org/government/commissions-appointments/planning Proposers are responsible for accessing this link to review the names prior to answering the following questions.

1. Have you or your company, or any agent/board member on behalf of you or your company/entity, made any political contributions of more than $250 to any Lancaster City Council Member or other city official in the 12 months preceding the date of the submission of your proposal or application, or the anticipated date of any Council action? YES If yes, please identify the Council Member(s)/city official(s):

NO

2. Do you or your company/entity, or any agency on behalf of you or your company/entity, anticipate or plan to make any political contribution of more than $250 to any Lancaster City Council Member or other city official in the 12 months following any Council action related to your proposal or application? YES If yes, please identify the Council Member(s) /city official(s):

NO (Please note that if this is a contract lasting more than one (1) year that you must update this form if there are any contributions made after the contract is awarded) Answering yes to either of the two questions above does not preclude the Lancaster City Council from awarding a contract or approving an application or any subsequent action. It does however, preclude the identified Council Member (s) from participating in any actions related to your proposal or application. _________________ _____________________________
Date Signature of authorized individual
_____________________________
Company/Applicant Name

12. References 1. Centers for Disease Control and Prevention. Drug overdose deaths in the U.S. top 100,000 annually. U.S. Department of Health and Human Services. Published May 2022. Accessed September 11, 2025. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm 2. Cohen SL, Bikson M, Badran BW, George MS. “A visual and narrative timeline of US FDA milestones for transcranial magnetic stimulation (TMS) devices.” Brain Stimul. 2022;15(1):73-75. doi:10.1016/j.brs.2021.11.010 3. Lefaucheur JP, Aleman A, Baeken C, et al. “Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018).” Clin Neurophysiol. 2020;131(2):474-528. doi:10.1016/j.clinph.2019.11.002 4. Ballester J, Marchand WR, Philip NS. “Transcranial magnetic stimulation for methamphetamine use disorder: A scoping review within the neurocircuitry model of addiction.” Psychiatry Res. 2024;338:115995. doi:10.1016/j.psychres.2024.115995 5. Gay A, Cabe J, De Chazeron I, et al. “Repetitive transcranial magnetic stimulation (rTMS) as a promising treatment for craving in stimulant drugs and behavioral addiction: A meta-analysis.” J Clin Med. 2022;11(3):624. doi:10.3390/jcm11030624 6. Harmelech T, Hanlon CA, Tendler A. “Transcranial Magnetic Stimulation as a Tool to Promote Smoking Cessation and Decrease Drug and Alcohol Use.” Brain Sciences. 2023;13(7):1072. doi:10.3390/brainsci13071072 7. Cole EJ, Phillips AL, Bentzley BS, et al. “Stanford Accelerated Intelligent Neuromodulation Therapy for treatment-resistant depression.” Am J Psychiatry. 2020;177(8):716-726. doi:10.1176/appi.ajp.2019.19070720 8. Nexstim Plc. Nexstim NBS System 5 User Manual. Helsinki, Finland: Nexstim Plc; 2023. 9. Mehta DD, Praecht A, Ward HB, Sanches M, Sorkhou M, Tang VM, Steele VR, Hanlon CA, George TP. “A systematic review and meta-analysis of neuromodulation therapies for substance use disorders.” Neuropsychopharmacology. 2024;49(4):649-680. doi:10.1038/s41386-023-01776-0 10. M. Grall-Bronnec, A. Sauvaget. “The use of repetitive transcranial magnetic stimulation for modulating craving and addictive behaviours: A critical literature review of efficacy, technical and methodological considerations.” Neuroscience and Biobehavioral Reviews 47 (2014) 592–613. 11. Liu X. Zhao X, Liu T, Liu Q, Tang L, Zhang H, Luo W, Za R, Daskalakis J Yuan T-F. “The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.” EBioMedicine 56 (2020) 102809 12. Soleimani G, Joutsa J, Moussawi K, Siddiqi SH, Kuplicki R, Bimson M, Paulus MP, Fox MD, Hanlon CA, Ekhtiari H. “Converging Evidence for Frontopolar Cortex as a Target for Neuromodulation in Addiction Treatment.” Am J Psychiatry. 2024;181(2):100-114. doi:10.1176/appi.ajp.20221022 13. Hanlon CA, Dowdle LT, Moss H, Canterberry M, George MS. “Mobilization of medial and lateral frontal-striatal circuits in cocaine users and controls: An interleaved TMS/BOLD functional connectivity study.” Neuropsychopharmacology. 2016;41(12):3032-3041. doi:10.1038/npp.2016.114

BIOGRAPHICAL SKETCH NAME John J. Whalen III, Ph.D. POSITION TITLE Biomedical Engineering Researcher. Fluid Synchrony eRA COMMONS USER NAME (credential, e.g., agency login) jackwhalen3 EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) INSTITUTION AND LOCATION DEGREE (if applicable) MM/YY FIELD OF STUDY The Johns Hopkins University, Baltimore MD B.S. 05/98 Biomedical Engineering The Johns Hopkins University, Baltimore MD M.S. 05/00 Materials Science & Eng The Johns Hopkins University, Baltimore MD Ph.D. 08/04 Materials Science & Eng Doheny Eye Institute, Los Angeles CA Post-Doc 05/06 Ophthalmology Research Fellow A. Personal Statement Dr. Whalen is leading the clinical research initiatives at the Brainstim Centers Inc., supporting its founder Dr. Mark Liker. Whalen leverages his experience in the field of invasive neuromodulation to develop a pathway to broader adoption of non-invasive neuromodulation by pursuing research initiatives to shed more light on understanding the mechanisms and objective effects of transcranial magnetic stimulaiton (TMS) on conditions like traumatic brain injury, post-concussion syndrome, tinnitus, depression and other conditions. Dr. Whalen is a biomedical engineer and materials scientist by training, with a career focus in early-stage medical device product development. As a graduate student and post-doctoral fellow, he published and patented research in novel implantable microelectrode materials for neuromodulation as well as supported development activities for USC’s Retinal Prosthesis project – an effort to develop an implantable microelectronic device to treat blindness caused by retinal degenerative diseases. Dr. Whalen is a trained expert in electrochemistry for materials deposition and materials characterization, and experienced in a number of other materials characterization techniques. While employed at Aspire Bariatrics Inc., Dr. Whalen was one of a small (6 person) management team that drove clinical development of a novel implant for treatment of obesity. Dr. Whalen was responsible for setup and management of outside-US pilot clinical trials (University of Nuevo Leon Medical Center, Monterrey, MX) and through US feasibility clinical trials (Wash U. Medical Center, St. Louis MO). The device received FDA PMA approval in summer 2016 and has raised over $20 Million in funding. While in that role, Dr. Whalen was integral in the setup and management of both clinical trials along with preparation of IRB, FDA and other regulatory body notifications and reports. Dr. Whalen served as a clinical engineer while at Aspire, providing feedback to engineering teams as well as troubleshooting malfunctioning devices, performing device failure analyses when needed, and supporting preparation of patent documentation. Dr. Whalen has served as the Director of Business Development and Industry Partnerships for U. Southern California’s NSF-sponsored “Biomimetic Microelectronic Systems (BMES) Engineering Research Center”. The center’s mission is the development of novel and industry-disruptive implantable microelectronic technologies. His primary duties included recruitment and engagement of medical device companies for the purpose of driving BMES technologies towards commercialization. Other activities driven included: creation and management of technology development programs to further incubate technologies, negotiation of technology licensing agreements, acquisition of industry sponsored research programs. Dr. Whalen has raised for BMES over $800,000 in industry membership fees and over $2.5 Million for BMES in collaborative projects with industry.

B. Positions and Honors POSITIONS: 2000-2004: Graduate Research Assistant. Electrochemistry Laboratory. PI: Dr. Peter Searson. The Johns Hopkins University. ARCS Fellowship Recipient (DC Chapter, 2001, 2003 awardee) 2004-2006: Post-Doctoral Research Fellow. Bioelectronics Laboratory. PI: Dr. James Weiland. U. Southern California’s Doheny Eye Institute. 2006-2010: Project Manager and Clinical Study Manager. Aspire Bariatrics, Inc. (King of Prussia, PA). 2009-2012: Director of Business Development & Industry Relations. NSF-Sponsored “Biomimetic Microelectronic Systems Engineering Research Center”. U. Southern California. 2012-2019: Founding CEO of Platinum Group Coatings, LLC. (www.platinumgroupcoatings.com) 2012-2019: NSF Industry Liaison Consultant (NSF ERC Program Consultant). Elysium Holdings, LLC. 2015-present: Assistant Professor of Research in Ophthalmology. USC Roski Eye Institute. U. Southern California. 2020-present: CEO of EPIC Medical Inc. (formerly known as Platinum Group Coatings LLC). 2024-present: R&D Director for Brainstim Centers Inc. HONORS and AWARDS: 2001: Achievement Rewards for College Scientists (ARCS) Foundation Scholar. (Washington D.C. Chapter). For research in characterizing electrodeposited nanomaterials. 2003: Achievement Rewards for College Scientists (ARCS) Foundation Scholar. (Washington D.C. Chapter). For research in nanomaterials for functional retinal stimulation. C. Contributions to Science 1. Advanced Materials for Functional Neuromodulation. Functional neurostimulation continues to push hardware towards designs with smaller electrodes and more channels to enhance precision and functionality. A further complication is that the number of conductive materials available to use for sustained implantation to interface the body are limited to platinum group of metals (Pt, Ir, etc.). It is well known that platinum-iridium alloys improve charge injection performance over conventional platinum, however processing of these alloys have been limited to high temperature metallurgical processes and thin film semiconductor processes. Here we developed a low-cost alternative using electrochemical deposition to co-deposit iridium with platinum while forming hydrous oxides. The result is a thin film electrode material with charge injection characteristics 10× greater than existing material technologies. a. A. Petrossians, J.J. Whalen III, J.D. Weiland, J.D. & F.B. Mansfeld. “Electrodeposition of platinum/iridium (Pt/Ir) on Pt microelectrodes with improved charge injection properties.” United States Patent US/8,795,504. b. C.D. Lee, E.M. Hudak, J.J. Whalen III, A. Petrossians, J.D.Weiland. “Low-Impedance, High Surface Area Pt-Ir Electrodeposited on Cochlear Implant Electrodes.” J. Electrochemical Society. 165 (12) (2018) G3015-G3017. c. I.R. Cassar, C. Yu, J. Sambangi, C.D. Lee, J.J. Whalen III, A. Petrossians, W.M. Grill. “Electrodeposited Platinum-Iridium Coating Improves in vivo Recording Performance of Chronically Implanted Microelectrode Arrays.” Biomaterials. 205 (2019) 120-132. d. A.N. Dalrymple, M. Huynh, U.A. Robles, J.B. Marroquin, C.D. Lee, A. Petrossians, J.J. Whalen III, D. Li, H.C. Parkington, J.S. Forsythe. “Electrochemical and Mechanical Performance of Reduced Graphene Oxide, Conductive Hydrogel, and Electrodeposited Pt-Ir Coated Electrodes: An Active in vitro study.” J. or Neural Engineering. V17 N1 23. Dec 2019. 016105 2. Advanced Materials for Treatment of Ocular Trauma Ocular trauma in combat casualties and mass casualty settings is a major challenge, because first responders and physicians must mana66ge multiple injuries with limited resources, and vital injuries always take precedence over non-vital injuries. This is of particular concern in visual system trauma, because these injuries are often not life threatening, however delayed intervention does result in permanent vision loss – a condition which has profound impact on quality of life and cost of care for the individual and society. Our group has focused on the development of novel materials-based technologies for simple but effective intervention of ocular trauma. The basic principle of these technologies is to provide a temporary patch to occlude penetrating injuries and prevent further loss of ocular tissue and viability, until the patient can be seen by a specialist with full microsurgical facilities. One of our projects uses a reversibly viscous hydrogel to occlude penetrating injuries to the eye based on the biomaterial poly N-isopropyl acrylamide (PNIPAM). Here we have demonstrated that eyes sustaining penetrating injuries and occluded with the hydrogel exhibit statistically significant improvements in intraocular pressure over the current standard of care (no intervention). Our second program uses reversibly attachable adhesive contact lenses, which use adhesive proteins to temporarily attach the lens to the eye, to treat corneal lacerations. Preliminary data suggests that this approach provides an improvement in intraocular pressure. a. J.J. Whalen III, Y. Zhang, P. Falabella, N. Bayat, M.E. Thompson, M.S. Humayun. “Polymeric Shield to Reduce Conjunctival Scarring and Facilitate Re-Access for Multistage Surgical Procedures.” Invest Ophthalmol Vis Sci (2015); b. Y. Zhang, J.J. Whalen III, P. Falabella, N. Bayat, M.E. Thompson, M.S. Humayun. “Efficacy Studies of Thermoresponsive Reversible Adhesive for Temporary Intervention in Ocular Trauma Utilizing a Rabbit Model.” Invest Ophthalmol Vis Sci (2015); c. N. Bayat, Y. Zhang, P. Falabella, R. Menefee, J.J. Whalen III, M.S. Humayun, M.E. Thompson.”A Reversible Thermoresponsive Sealant for Temporary Closure of Ocualr Trauma.” Science Translational Medicine. 9 (2017). d. B. Li, J.J. Whalen III, M.S. Humayun, M.E. Thompson. “Reversible Bioadhesive Using Tannic Acid Primed Therally-Responsive Polymers.” Advanced Functional Materials. 2019, 1907478 (1-10). 3. Advanced Materials for Retinal Prosthesis Applications Implantable retinal prostheses for vision restoration use microelectrode arrays to electrically stimulate vision in patients with advanced retinal degenerative diseases. This application for neuromodulation requires reducing electrode size so as to maximize the number of stimulator electrodes for the purpose of maximizing visual resolution. Conventionally processed platinum electrodes cannot meet these performance requirements. An approach to surpassing this dimensional limit is to introduce nanotexturing to the electrode surface by electrochemical deposition of platinum, to increase the surface area in the 3rd dimension. We have developed a number of different strategies to reducing electrochemical impedance through electrochemical deposition of nano-textured platinum from neutral plating solutions. Unlike chloroplatinic acid based systems, these plating solutions prevent co-reduction of hydrogen during platinum deposition, thus enabling less stressed thin films. High aspect ratio platinum nanowire arrays have been formed as well as a number of high surface area thin film coatings, which exhibit charge densities up to 10x greater than conventional platinum electrodes. These materials are also patented for use as high-density feedthroughs for implantable microelectronic packaging. a. J.J. Whalen III, J.D. Weiland, P.C. Searson, “Electrochemical deposition of platinum from aqueous ammonium hexachloroplatinate solution.” Journal of Electrochemical Society, 152 (2005) C738-C743. b. J.J. Whalen III, J. Young, J.D. Weiland, P.C. Searson. “Electrochemical characterization of charge injection at electrodeposited platinum electrodes in phosphate buffered saline.” Journal of Electrochemical Society, 153 (2006) C834-C839. c. J.J. Whalen III, J.D. Weiland, M.S. Humayun, “Microelectrode system for neuro-stimulation and neuro-sensing and microchip packaging.” United States Patent US/8,195,266. d. M.S. Humayun, A.P. Rowley, J.J. Whalen, J.D. Weiland, A.R. Tanguay Jr. “The Development of a Retinal Prosthesis: A Significant Biomaterials Challenge." Biomaterials Science: An Introduction to Materials in Medicine. 3rd Ed., December 2012. Chapter II.5.9.E, pp 946-957. More Complete List of Published Work in ResearchGate: https://www.researchgate.net/profile/John_Whalen8/publications Thomas A.S. Deuel, MD, PhD Neurology, Clinical Neurophysiology, Neuroscience 3213 S Norman St. Seattle, WA 98144 (617) 953-7961 [email protected] EMPLOYMENT Legacy Health, Vancouver WA Staff Physician, Neurohospitalist 3/1/25- present Swedish Hospital, Seattle WA Staff Physician, Neurophysiologist 8/1/12- present University of Washington, Seattle WA Acting Assistant Professor, Center for Digital and Experimental Art (DXArts) and School of Music 2014- present Medical Consultants Network, WA Independent Medical Examiner 2017- present Weatherby Healthcare Locum Tenems Neurology 2022- present Providence St Patrick Hospital, MT Neurohospitalist, Neurophysiologist 2023- present EDUCATION/TRAINING Princeton University B.A. 9/1990-6/1994 Molecular Biology Harvard Medical School/M.I.T. M.D. 9/1997-6/2006 Medicine Harvard Medical School Ph.D. 9/1999-8/2004 Neurobiology New England Conservatory Certificate (Jazz) 2000-4 Music Composition, Performance Yale-New Haven Hospital Internship 7/2006-6/2007 Internal Medicine Partners Healthcare (MGH/BWH) Residency 7/2007-6/2010 Neurology Residency Beth Israel-Deaconess Medical Center Fellowship 7/2010-6/2011 Neurophysiology (Epilepsy) U. of Washington, Harborview Hospital Fellowship 7/2011-6/2012 Neurophysiology (Epilepsy) CERTIFICATIONS American Board of Psychiatry and Neurology, 2012-present Emergency Neurological Life Support, 2020 Independent Medical Examiner, State of Washington, 2017 MEDICAL LICENSURE Washington State, active Oregon State, active Montana State, expired 2024 Massachusetts, expired 2013 CLINICAL SUBSPECIALTY SKILLS: EEG, Neurophysiology, acute stroke/thrombolysis/thrombectomy INVITED TALKS 2024 Northwest Voice: The Art and Science of the Performing Voice Conference 2022 Grand Rounds, University of Washington, Dept. of Neurology 2020 TEDx Seattle, Seattle, WA 2018 IRCAM Forum, Centre Georges Pompidou, Paris France 2017 Pacific Northwest Psychological Society, Seattle WA 2017 Audio Engineering Society (AES), Digipen, Bellvue, WA 2016 MIT Enterprise Forum NW, "Augmented Humans", Town Hall Seattle WA 2015 Microsoft Research, Microsoft Building 99, Redmond WA 2015 Art and Technology Forum, Institute for Systems Biology, Seattle WA 2015 Conversations on Art and Culture, Vermillion Gallery/Performance, Seattle WA TEACHING EXPERIENCE 2015-25 Lecturer, DXArts 490: Art and Brain, University of Washington 2014 Lecturer, Advanced Seizure management for Fellows, Swedish Medical Center 2014 Invited Speaker, Cerebrovascular Symposium, Swedish Neuroscience Institute 2013 Graduate Student Mentor, DXArts 500 Graduate Seminar, University of Washington 2013 Guest Lecturer, DXArts 500 Graduate Seminar, University of Washington 2012-present Medical Student Neurology clinical teaching to University of Washington Students 2011 Lecturer, Basics of Epilepsy for Residents, University of Washington 2000-2002 Head Teaching Assistant, Introduction to Neuroscience Course, Harvard Medical School 2000 Teaching Assistant, Introduction to Neuroscience Course, Harvard Medical School RESEARCH EXPERIENCE 2012-present Principal Investigator, Director, Deuel Studio/lab, Seattle WA 2011- 2012 Research Fellow, University of Washington, Laboratory of Felix Darvas 2010-2011 Research Fellow, Massachusetts General Hospital, Laboratory of Syd Cash 2001-2004 PhD Candidate, Harvard U. Program in Neuroscience, Laboratory of Christopher Walsh 2000 PhD Rotation Student, Division of Neurology, Beth Israel Hospital, Harvard Medical School, Boston, Laboratory of Christopher Walsh 1999-2000 PhD Rotation Student, Division of Neuroscience, Children’s Hospital, Harvard Medical School, Boston, Laboratory of Jeffrey Macklis 1998-1999 Medical Student Research Assistant, Division of Neuroscience, Children’s Hospital, Harvard Medical School, Boston, Laboratory of Jeffrey Macklis 1994-1997 Research Associate, Center for Neurobiology and Behavior, Columbia University, Laboratory of Eric Kandel 1993-1994 Undergraduate Laboratory Assistant, Dept. of Molecular Biology, Princeton University, Laboratory of Yashua Hiromi AWARDS AND GRANTS 2017-18 National Endowment for the Arts, Creativity Connects 2017 Discover Magazine, top 100 science stories of 2017 2016 9e2 Seattle Artist grant (for group performance), Seattle WA 2016 4Culture Tech-Specific Arts Grant (for group performance), Seattle WA 2015 Exhibiting Artist Award, Megapolis Audio Festival, San Francisco CA 2012 Board Certification, American Board of Psychiatry and Neurology 2010 Top Scholar Travel Grant – American Epilepsy Society 2010 Exhibiting Artist Award, Megapolis Audio Festival, Baltimore MD 2010- American Epilepsy Society (AES) 2006- American Association of Neurology (AAN) 2004-2005 Harvard Center For Neurodegeneration and Repair Fellowship 2002-2003 Stuart H.Q. & Victoria Quan Fellowship in Neuroscience 1997- Massachusetts Medical Society 1998 NIH Neurobiology Training Grant 1993 Howard Hughes Medical Institute Undergraduate Summer Research Fellowship PUBLICATIONS Deuel TA, Wenlock J, McGovern A , Rosenthal J, Pampin J. (2025). Musical auditory feedback BCI: clinical pilot study of the Encephalophone. Frontiers in Human Neuroscience. 19.10.3389/fnhum.2025.1592640. Deuel TA, Pampin J, Wenlock J, Rosenthal J. Clinical Trials of the Encephalophone Music Prosthetic for the Motor Impaired. 15th International Conference on Music Perception and Cognition, 10th triennial conference of the European Society for the Cognitive Sciences of Music. Graz, Austria, July 2018 Deuel TA, Pampin J, Sundstrom J and Darvas F (2017) The Encephalophone: A Novel Musical Biofeedback Device using Conscious Control of Electroencephalogram (EEG). Front. Hum. Neurosci. 11:213. doi: 10.3389/fnhum.2017.00213 Deuel TA, Pampin J, Sundstrom J, Darvas F. The Encephalophone: A novel brain-computer music interface and cognitive rehabilitation device using conscious control of electroencephalogram (EEG); Presentation number 540.16: Society for Neuroscience Annual Meeting, Chicago, IL Oct 20, 2015. Chao FC, Deuel TA, Venna N., 2010, Neurologic Infectious Diseases, in Greer, D. ed., Pocket Neurology, Lippincott Williams & Wilkins pp149-167. Deuel TA* Liu JS*, Corbo JC, Yoo SY, Rorke-Adams LB, Walsh CA. Genetic interactions between Doublecortin (Dcx) and the Doublecortin-like kinase (Dclk-1) in neuronal migration and axon outgrowth. Neuron 2006 Jan 5;49(1):25-39. Corbo JC, Deuel TA, Long JM, LaPorte P, Tsai E, Wynshaw-Boris A, Walsh CA. Doublecortin is required in mice for lamination of the hippocampus but not the neocortex. J Neurosci. 2002 Sep 1;22(17):7548-57. Abel T. Nguyen PV. Barad M. Deuel TA. Kandel ER. Bourtchouladze R. Genetic demonstration of a role for PKA in the late phase of LTP and in hippocampus-based long-term memory. Cell 88(5):615-26 (1997). Patterson SL. Abel T. Deuel TA. Martin KC. Rose JC. Kandel ER. Recombinant BDNF rescues deficits in basal synaptic transmission and hippocampal LTP in BDNF knockout mice. Neuron 16(6):1137-45 (1996). LANGUAGES SPOKEN French Spanish