Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder
Phase: NA
Conditions: Alcohol Use Disorder (AUD), Transcranial Magnetic Stimulation
Sponsor: VA Palo Alto Health Care System

Examining the Effectiveness of Deep TMS in Veterans with Alcohol Use Disorder 
Protocol Number:  IRB-54988.  NCT04927364. 
Principal Investigator:  Claudia Padula, PhD. 
Funded by: Innovator Grant from Stanford 
Version: as of June 28, 2022 
Brief Summary 
The purpose of this study is to evaluate the efficacy of deep transcranial 
magnetic stimulation as a treatment for Veterans with an alcohol use disorder 
(AUD) to decrease the exceedingly high rate of relapse associated with this 
condition. 
Objectives 
At least 60% of those with AUD will experience a major relapse period within 6 
months of treatment, irrespective of the intervention (psychosocial and/or 
pharmacological) employed. Consequently, the high prevalence of AUD and 
relapse following treatment in Veterans is associated with substantial resource 
allocation and costs for the VA Health Care System. Current pharmacological and 
psychosocial interventions demonstrate only a moderate level of efficacy, which 
is reflected in the high rate of relapse in AUD. TMS is a neurostimulation method 
that is at the forefront of innovative, non-invasive, and safe treatments for AUD, 
and other psychiatric disorders. To reduce the high rate of relapse in Veterans 
with AUD, it is necessary for interventions to more effectively address the 
associated neurobiological dysfunction. Non-invasive neuromodulation 
techniques are showing promise toward the aim of modifying specific and 
selective neural targets related to AUD and relapse. However, device-based 
interventions to date for AUD have focused on cortical stimulation. In contrast, 
preclinical and clinical studies, including our research team’s preliminary data, 
suggest that subcortical nodes within the salience network could be promising 
novel neuromodulation targets. The dorsal anterior cingulate cortex (dACC) is a 
core node of the salience network, and hence the target of this proposal. Deep 
repetitive transcranial magnetic stimulation (dTMS) is one type of 
neuromodulation technique, and utilizing an H7 coil design can reach the dACC. 
Monitoring periodically throughout the first 6 months following treatment is 
crucial, given relapse within the first 6 months of treatment is robustly related to 
poor psychosocial functioning over the ensuing 1-3 years.  
The ultimate goal of this proposal is to provide treatment that more effectively 
promotes sustained abstinence in the Veteran with AUD, as extended abstinence 

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is robustly associated with optimum biomedical, neuropsychological, psychiatric, 
and psychosocial recovery and functioning 
Rationale for Research in Humans 
The goal of this study is to evaluate the effectiveness of deep TMS applied 
through the established H7 coil protocol as a treatment for Veterans with an 
AUD; therefore, humans must be studied. 
STUDY PROCEDURES 
Procedures: 
ALL RESEARCH ACTIVITIES WILL BE COMPLETED AT THE VA, 
WITH THE EXCEPTION OF THE MRI, WHICH WILL BE DONE AT STANFORD:  
Recruitment and screening: Participants will be recruited via the VA Palo Alto 
Addiction Treatment Services, Foundations of Recovery program. 
Informed Consent: Prior to consent, The PI, Co-Is, or qualified RA, will recheck 
inclusion/exclusion criteria. 
Baseline/Pretreatment Assessment: 
- Psychiatric Assessment
- Alcohol and Substance Use assessment
- 3 Tesla Magnetic Resonance Neuroimaging
- Breathalyzer, urine test, saliva collection
Treatment Phase: Participants will receive a total of 30 deep TMS treatments, 
delivered 3 times per day, over 10 consecutive business days, with minor 
schedule variability to allow for participants' regular program scheduling at the 
treatment centers. Since participants will be recruited from Palo Alto VA 
residential treatment programs, 24-hour monitoring for any adverse events will 
be in place as an additional layer of participant safety. During this time, all 
participants will be receiving treatment as usual at the VA clinics, and scheduling 
of TMS will be arranged so as not to interfere with their daily curriculum. 
Post-Treatment Phase: Within 3-4 days of completion of the Treatment Phase, 
all participants will repeat select psychiatric assessment measures, select alcohol 
and substance questionnaires, and 3 Tesla Magnetic Resonance Neuroimaging. 
Monthly Follow-ups: For the 6 months following completion of treatments, 
participants will be contacted at 2-, 4-, and 6- months post-participation, via 
telephone or in person, to complete brief standardized measures of alcohol and 
substance use, as well as craving to assess for changes in these variables over the 

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preceding 30 days. These brief contacts will be 10-15 min in duration and 
tracking sobriety is the primary outcome measure of this study. 
DETAILS OF RECRUITMENT, DESIGN AND TREATMENT 
Recruitment and screening:  
Potential participants from the VAPAHCS treatment programs will be identified 
based on VA medical/clinical staff diagnoses of an alcohol use disorder without 
any comorbid condition any conditions that be contraindicated for study (e.g., 
taking medications that lower seizure threshold, magnetic resonance 
neuroimaging contraindications, medically confirmed seizure disorder). 
Specifically, medical/clinical staff of the programs listed above will identify 
potential participants who meet eligibility criteria and inform the patient that a 
research opportunity is available to them and offer contact information to study 
personnel or the participant may request that study personnel contact them. 
The study has been explained to clinicians via treatment team meetings, so they 
are familiar with eligibility criteria. The PI, Co-Is, or qualified RA will check 
inclusion/exclusion criteria based on initial eligibility and sociodemographic data 
via in-person screen at the treatment program or at the MIRECC, Building 5, 4th 
floor. Private interview rooms are available for this purpose at both locations. 
Baseline/Pretreatment Assessment see section Innovator Grant application: 
a) Psychiatric Assessment: we will use standardized measures employed in
clinical practice and research.
b) Alcohol and Substance use: we will use standardized measures employed in
clinical practice and research. Participants will be asked to submit a urine sample
to screen for illegal/non-prescribed drug use and/or complete a breathalyzer to
screen for alcohol use.
c) 3 Tesla Magnetic Resonance Neuroimaging: will be conducted at Stanford
University CNI.
d) Saliva collection: Participants will be asked to provide a saliva sample for
genotyping.
Design, Treatment Phase, and Treatment Arms:  
This study will enroll 10 participants to receive deep TMS. Participants will 
receive 30 dTMS sessions over the course of 2 weeks. Participants will be 
required to be abstinent from alcohol and illicit substances for 7 days and 
demonstrate no clinically significant withdrawal symptoms prior to the pre-
assessment described above. 
Rationale for Brain Region Site and Technique: Converging lines of evidence 
support the salience network as a promising future neuromodulation target to 
impact treatment outcomes for AUD. However, most TMS studies to date have 
focused on cortical stimulation. In contrast, preclinical and clinical studies, 

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including our research team’s preliminary data, suggest that subcortical nodes 
within the salience network (SN) are promising novel neuromodulation targets. 
Based on this evidence, our study will utilize the H7 coil to administer deep TMS 
to core salience network nodes. See section 3A (paragraphs 1 and 2) for a more 
in-depth rationale for the brain region site. 
Duration of Treatment Phase: Participants will receive a total of 30 treatments 
over 10 consecutive days, allowing for minor scheduling variability so as not to 
interfere with regular program scheduling in the treatment programs. 
Participants will typically receive 3 treatments per day (Monday- Friday), over 2 
consecutive weeks; inter-treatment interval will be at least 2 hours. Sessions will 
typically be conducted prior to the beginning to the participants' treatment day, 
and at lunch, as to not interfere with their treatment-as-usual in the VA 
substance treatment clinics. 
Procedures for Delivery of dTMS Sessions: 
1. Motor Threshold MT Elicitation: Each subject will complete the motor
determination procedure (MT) as outlined by the device specifications for the H7
coil.
2. Anatomical localization to the medial PFC and the dACC: After MT, the TMS
helmet will be positioned to the treatment location by aligning the coil to the
center of the head and then moved 4 cm anterior to the optimal MT location
targeting the left and right prefrontal cortex with a preference to the left medial
PFC extending to the ACC.
3. Personalized Provocation Protocol: Review of the literature suggest that in
order to optimally modify neural networks associated with disease sites, priming
prior to treatment is suggested. Current FDA cleared H7 coil protocol for OCD
already implements this as standard clinical care. As such, the proposed study
will develop a personalized provocation protocol for each participant that will be
reviewed prior to the start of treatment in the study. During the baseline
assessment, participants will meet with trained clinical study staff (i.e., clinical
post-doctoral fellow or study PIs) and provided structured instruction on writing
a half-page narrative describing the situation or circumstances that triggered
their desire to quit. This narrative will be securely stored in order to be available
for participants prior to each treatment session regardless of the treatment
protocol they have been randomized. Before each dTMS treatment session, the
subject will be instructed to review this personalized narrative, not to exceed 5
minutes. Once they have reached a distress level ranging from 4 - 7 on a visual
analog scale, treatment pulses will be delivered.

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4. dTMS dosing: To minimize subject discomfort, an adaptation train will be
administered at the beginning of each treatment session followed by their
personalized treatment parameters calculated during the MT session at the
baseline visit. Device settings will be set for 100% of the subject’s measured MT
at a frequency of 20 Hz for 2 seconds at a time (train duration) with a 20-second
intertrain interval. Each subject will) receive 50 trains for a total of 2000 pulses
delivered per treatment session lasting approximately 18.5 minutes per session.
Each participant will receive 30 sessions totaling 60,000 pulses over the course of
treatment
Post-Treatment Phase: Within 3-4 days of completion of the Treatment Phase, 
all participants will repeat select psychiatric assessment measures, select alcohol 
and substance 
questionnaires, random urine substance screen and alcohol breathalyzer,3 Tesla 
Magnetic Resonance Neuroimaging as described above in Baseline/Pretreatment 
Assessment. 
Monthly Follow-ups: For the 6 months following completion of the treatment 
phase, participants will be contacted three times (2-, 4-, and 
6-months post-participation), via telephone or in person, to complete
brief standardized measures of alcohol and substance use, as well as
craving to assess for changes in these variables over the preceding 30 days.
These brief contacts will be 15-20 min and tracking sobriety is the primary
outcome measure of this study.
Procedure Risks 
All procedures will be performed by staff trained specifically for the tasks for 
which they are responsible. All procedures, including the rTMS, and are 
considered low-risk procedures. rTMS is regarded as safe and without lasting 
side effects when established guidelines are followed. The primary serious 
adverse event associated with transcranial magnetic stimulation procedures are 
seizures, however, the estimated prevalence is very low at < 1%. In the case of 
transcranial magnetic stimulation-seizures, all have occurred during stimulation, 
there was no recurrence of seizures, and no incidences of status epilepticus. 
There have been no significant adverse cognitive, brain structural, neurologic or 
cardiovascular sequelae reported as a result of rTMS. Seizure risk will be 
minimized by careful patient selection by rigorously screening and exclusion of 
participants with history of seizure disorders or other conditions and medication 
use that increases risks of seizure. A seizure protocol is in place to avoid 
participant injury in the unlikely event that a seizure does occur attached. 
The study will use the 3T UHP system at CNI. The UHP shares a common 
software and hardware architecture to GE's FDA-approved Premier system but 
uses a higher-performance gradient coil and is not FDA approved for diagnostic 

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use and is subject to the 21 CFR 812 investigational device(IDE) regulations as 
well as 21 CFR 50 and 56. The system has been tested by GE according to 
UL606001-1 and also for compliance with IEC 60601-2-33 (ed 3.1) - meeting 
limits and guidelines for peripheral nerve stimulation, patient thermal, SAR limit, 
acoustic noise, flammability rating UL94-5VA for safety covers, hydrostatic 
pressure, electrical hazards, dielectric strength and pinch point. The MRI scans in 
this study will also utilize operational parameters within FDA guidelines for 
Nonsignificant Risk thus an Investigational Device Exemption (IDE) from FDA 
should not be necessary. The research conducted under this protocol is not to 
evaluate the safety or efficacy of this device. In support of this research study, 
some of the image acquisition pulse sequences and post-processing software will 
be developed in collaboration with GE Healthcare. Any such software will be 
considered investigational, will function as a non-significant risk device, and is 
subject to the 21 CFR 812 investigational device(IDE) regulations as well as 21 
CFR 50 and 56. The investigational image acquisition software will conform to 
FDA guidelines for MR safety related to heating (SAR), peripheral nerve 
stimulation (dB/dt), and acoustic noise. 
Overall, the risks to participants in this proposal are reasonable in relation to 
anticipated benefits, if any, to the participants, and the importance of the 
knowledge that may be expected to result. 
a.
Use of Deception in the Study- N/A
b.
Use of Audio and Video Recordings-N/A
Alternative Procedures or Courses of Treatment 
The participants in this study will concurrently receive standard-of care 
cognitive-behavioral and pharmacological interventions from the VAPAHCS 
substance treatment clinics they are enrolled in. There are no potential risks the 
participants who receive concurrent cognitive-behavioral and any procedure 
associated with the proposed research protocol. No participant will be enrolled 
who is taking a medication that lowers seizure threshold. Risks to confidentiality 
will be minimized by following all procedures dictated by HIPAA. Of course, 
potential participants may decline to be involved in the study and receive only 
the available standard-of-care cognitive-behavioral and pharmacological 
interventions. 
This study will not impose any restrictions on treatment/therapy after 
conclusion. At this point, the dMS treatment under investigation will only be 
available during the treatment phase of the study. 
Study Endpoint(s) 

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In order to have sufficient power to evaluate the primary hypotheses of this 
study, it is expected to continue until all participants have completed the 
procedures and follow-up assessments. 
BACKGROUND
Past Experimental and/or Clinical Findings 
To date, TMS has emerged as a promising treatment avenue for AUD and is 
being tested in clinical trials with some encouraging results. The traditional 
target of the left dorsolateral prefrontal cortex (DLPFC) suggests that targeting 
the DLPFC alone may be insufficient, as treated individuals resume drinking 
shortly after treatment at similar rates as those receiving sham. One possible 
explanation is the well-documented atrophy of the PFC as a result of chronic 
heavy drinking. Therefore, targeting a structurally compromised brain region, 
may not yield the most robust effect. The literature describes how TMS 
treatment is associated with physiological changes in the brain at the treatment 
target area stimulated as well as in remote brain regions connected structurally 
or functionally. TMS has been associated with changes in long-term potentiation 
(LTP) or depression (LTD) to increase neuroplasticity through increases in brain-
derived neurotrophic factor (BDNF) and is implicated in influencing the 
excitatory/inhibitory balance of GABAergic synapses. Given the demonstrated 
downstream impact, novel approaches for stimulation need to occur. 
An emerging advancement is the use of coils that target deeper regions of the 
brain and have the potential of targeting multiple, interacting brain networks. 
The coil configuration in this technique (and proposed in this study) stimulates a 
broader area (volume of stimulation is 40.3 cm^3), as well as a deeper area 
(subdural depth is 3cm). Through the use of this less commonly used coil type 
(H7), we hypothesize that we will be able to modify core nodes within the 
salience network that are otherwise not reached through traditional figure-of-
eight coil approaches. Notably, there are only two published studies to date that 
utilize these H-coils for AUD, and only one focusing on the H7 coil proposed in 
this study. Harel and colleagues (2022) recently reported that an H7 stimulation 
protocol similar to the one proposed here resulted in changes in functional 
connectivity AND lower heavy drinking days in the active condition compared to 
the sham condition. However, it remains unclear if the proposed stimulation 
strategies will have an objectively measurable impact on their respective brain 
targets. 
The proposed project will begin to explore if deep TMS treatments will be 
associated with 1) changes in task-based activation to emotional stimuli and 2) 

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whether these changes are associated with a reduced risk of relapse after 
standard VA treatment. 
We believe this proposed work will provide preliminary data for a larger grant 
submission that could allow for a more complex study design to fully answer 
gaps in current knowledge about deep TMS H7 coil as a possible treatment 
approach for AUD. 
2.
DEVICES USED IN THE STUDY
Investigational Devices (Including Commercial Devices Used Off-Label)
Investigational Device 1 
Name: 
3T UHP 
Description: 
GE 3T Ultra High Performance (UHP) MRI scanner GE Healthcare 
Significant Risk? (Y/N) 
No 
Rationale for Non-Significant Risk 
The GE 3T Ultra High Performance (UHP) MRI scanner is an upgrade of an 
FDA-approved 3T MR750 scanner but is not itself FDA approved. The 
UHP scanner utilizes components from GE's 3T Signa Premier scanner (an 
FDA approved system) including gradient drivers, power supply, transmit 
and receive system, but uses a higher-performance gradient coil. The 
scanner has been tested by GE according to UL606001-1 and for 
compliance with IEC60601-2-33 (ed 3.1), meeting limits and guidelines 
for peripheral nerve stimulation, patient thermal, SAR limit, acoustic 
noise, flammability rating UL94-5VA for safety covers, hydrostatic 
pressure, electrical hazards, dielectric strength and pinch point. MRI 
research scans also frequently require specialized research software, but 
this will conform to FDA guidelines for MR safety related to heating 
(SAR), peripheral nerve stimulation (dB/dt), and acoustic noise. As a 
result, the 3T UHP system is considered a non-significant risk 
investigational device and is subject to 21 CFR 812 investigational device 
(IDE) regulations as well as 21 CFR 50 and 56. The MRI scans in this study 
using the UHP scanner will utilize operational parameters within FDA 
guidelines for Nonsignificant Risk thus an Investigational Device 
Exemption (IDE) from FDA should not be necessary. In addition to the GE 
receive coil components that are included with the UHP system, there 
are some non-GE coils. These devices are legally marketed components, 
used in accordance with their labelling, and are of non-significant risk. 
They include 32 channel and 16 channel receive-only brain RF coil arrays, 
manufactured by Nova Medical, Inc. 
Investigational Device 2 
Name: 
BrainsWay Deep TMS H7 coil 
Description: 
Deep TMS is FDA-cleared for other impulse control disorders and 
specifically the BrainsWay H7 Deep TMS coil was FDA-approved for OCD 
in September 2017 (DEN170078)101.  
Significant Risk? (Y/N) 
No 
Rationale for Non-Significant Risk 
Deep TMS is FDA-cleared for other impulse control disorders and 
specifically the BrainsWay H7 Deep TMS coil was FDA-approved for OCD 
in September 2017 (DEN170078)101. Review of the clinical summaries 

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submitted to the FDA demonstrated that this technology is clinically 
efficacious and safe for individuals with these conditions. Although the 
Brainsway dTMS system is not FDA-approved for alcohol use disorder, 
the device presents non-significant risk since it is an FDA-approved 
device that is not intended as an implant, will be used in supporting or 
sustaining human life, is of substantial importance in treating AUD since 
participants will continue with standard of care, or otherwise presents a 
potential for serious risk to the health, safety or welfare of a subject. 
IDE-Exempt Devices- N/A 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
Investigational Drugs, Biologics, Reagents, or Chemicals-N/A 
Commercial Drugs, Biologics, Reagents, or Chemicals-N/A 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND ANIMALS-N/A 
PARTICIPANT POPULATION 
Planned Enrollment   
10 Veteran participants are expected to be enrolled from the VAPAHCS Foundations of 
Recovery (FOR), a 28-day residential program. 
Age, Gender, and Ethnic Background 
The study will be open to males and females, regardless of race and ethnic origin, 21-70 
years of age, who are in active treatment for an AUD at the VAPAHCS. The 21-70 age 
range was chosen given the vast majority of information on rTMS efficacy and safety has 
been obtained from this range and this is the typical age range of Veterans seeking 
treatment for AUD at the VAPAHCS. 
Vulnerable Populations 
Individuals with the following conditions that are associated with decisional impairment 
will be excluded: History of schizophrenia spectrum disorders, bipolar disorders, 
neurodegenerative diseases (e.g., Alzheimer disease, Parkinson's disease) patients with 
a previous clinical flag for risk for suicide will be required to have an established safety 
plan involving their primary psychiatrist and the treatment team before entering the 
clinical trial. Anyone with active current suicidal intent or plan will be excluded. 
Individuals with a lack of fluency in English, Wechsler Adult Reading Test below the 7th 
percentile (i.e., moderate or greater impairment in estimated general intelligence), 
females who are pregnant or actively attempting pregnancy, using conservative 
exclusion for magnetic resonance research will also be excluded from the study. It is 
common for Veteran AUD and substance use samples to contain economically and 

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educationally disadvantaged; however, no undue influence will be exerted on these 
individual and level of compensation for study participation will not be coercive. 
Additionally, the treatment phase of this study will occur while participants are receiving 
standard-of-care treatment at the VAPAHCS, which will permit additional on-going 
monitoring for any adverse events. 
Rationale for Exclusion of Certain Populations 
No children will be involved in this project as they are not in the age range of US Armed 
Services Veterans. The study will be open to male and females, regardless of race, ethnic 
origin, and sexual preference and identity, 21-70 years of age, who are in active 
treatment for an AUD at the VAPAHCS. Approximately 5% females and 40% racial and 
ethnic minorities were observed among the Veteran participants in PI's previous studies 
at the VA Palo Alto. Given the similar demographics of Veterans at the VAPAHCS, we 
anticipate a similar distribution of females and racial and ethnic minorities. 
Stanford Populations 
It is possible that up to 2 of our participants may be current VA laboratory personnel or 
employees. We do not anticipate that any Veteran participants will be current Stanford 
employees or students. 
Healthy Volunteers  
No healthy volunteers will be included in this study. 
Recruitment Details 
Potential participants from the VAPAHCS treatment programs (Foundations of 
Recovery) will be identified based on VA medical/clinical staff diagnoses of an 
alcohol use disorder without any comorbid condition any conditions that be 
contraindicated for study e.g., taking medications that lower seizure threshold, 
magnetic resonance neuroimaging contraindications, medically confirmed seizure 
disorder. The study protocol has been explained to medical/clinical via treatment 
team meetings, and they are fully cognizant of study procedures and eligibility 
criteria. Medical/clinical staff of the programs listed above will identify potential 
participants who meet eligibility criteria and will verbally inform them that there is a 
VA-sponsored treatment they may be interested in; the medical/clinical staff offer 
contact information for study personnel or the participant may request to the 
medical/clinical staff that study personnel contact them. In this way, the participant 
is self-referred to the study. The PI, VA-based Co-Is or qualified RA will check 
inclusion/exclusion criteria based on initial eligibility and sociodemographic data via 

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in person screen at the treatment program or at the MIRECC, Building 5, 4th floor. 
Private interview rooms are available for this purpose at both locations. 
Eligibility Criteria 
Inclusion Criteria 
The study will be open to male and females, regardless of race and ethnic origin, 21-
70 years of age, who are in active treatment for an AUD at the VAPAHCS, 
Foundations of Recovery. 
An age range of 21-70 at time of enrollment was chosen given the vast majority of 
information on rTMS efficacy and safety has been obtained from this range and this 
is the typical age range of Veterans seeking treatment for AUD at the VAPAHCS. 
Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th 
Edition (DSM-5) criteria for AUD, and alcohol is self-identified as primary substance 
of misuse. 
Able to read, verbalize understanding, and voluntarily sign the Informed Consent 
Form prior to participation in study procedures in English. 
Participants will be accepted if taking medications specifically for the treatment of 
major depressive disorders, cigarette smoking, or for other psychiatric conditions as 
long as the medications are not documented to lower seizure threshold - it would 
be clinically contraindicated to require participants to discontinue such medications 
for research. rTMS is safely administered to individuals who are taking psychotropic 
medications that do not lower seizure threshold. 
Participants will be abstinent from alcohol and non-prescribed substances for at 
least 7 consecutive days prior to rTMS to ensure no participant is experiencing 
active acute withdrawal. 
Exclusion Criteria 
Psychiatric: Current diagnosis of Schizophrenia Spectrum Disorders and Bipolar 
Disorders; a current moderate-severe substance use disorder other than alcohol, 
tobacco, or marijuana, based on DSM-5 diagnostic criteria; active current suicidal intent 
or plan (patients with a previous clinical flag for risk for suicide will be required to have 
an established safety plan involving their primary psychiatrist and the treatment team 

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before entering the clinical trial, any form of previous rTMS or electroconvulsive 
treatment) 
Biomedical: Including, but not limited to uncontrolled thyroid disease, unstable 
congestive heart failure, angina, other severe cardiac illness as defined by treatment 
regimen changes in the prior 3 months, cerebrovascular accident, cancer if < 1 year 
since end of treatment; unstable diabetes, COPD requiring oxygen supplementation, 
Alzheimer's disease, Parkinson's disease, any biomedical implants with ferromagnetic 
content, neurostimulation devices, cardiac pacemakers or any magnetic resonance 
contraindications; traumatic brain injury with self-reported or observed loss of 
consciousness > 30 minutes, any primary or traumatically induced seizure disorder, and 
alcohol-related seizure(s) in the past 30 days. 
General: Lack of fluency in English; Wechsler Adult Reading Test below the 7th 
percentile (i.e., moderate or greater impairment in estimated general intelligence); 
females who are pregnant or actively attempting pregnancy; conservative exclusion for 
magnetic resonance research, current use of any medication or substance that is 
documented to lower seizure threshold or has been identified as a contraindication for 
rTMS treatment. 
Screening Procedures  
1) Initial screen for alcohol use disorder undertaken by the treatment program clinical staff
at intake, with the support of the director. The clinical staff will offer each incoming patient
with a diagnosis of AUD the opportunity to participate in the study, and refer to the
potential participant to the PI, Co-I or trained RA's study contact number, and the PI, Co-I or
trained RA's will answer/return the potential participant's call; alternately, the potential
participant can request to the clinical staff that PI, Co-I or trained RA's contact in-person at
the VAPAHCS treatment program them to further explain the study.
2) If the potential participant is interested in the study, the PI, Co-I, or trained RA will then
conduct an in-person screen for study-specific inclusion and exclusion criteria. We are
requesting a waiver of authorization for this recruitment process. Eligible participants will be 
invited to complete the Informed Consent document and enroll in the study. Ineligible
participants will be immediately informed that they do not satisfy inclusion/exclusion
criteria. Ineligible participants will not be given the specific reasons why they are not eligible
in order to maintain the integrity
and security of the study inclusion/exclusion criteria. Rather, ineligible participants will be
informed that they have a current or past history of medical, physical, or psychological
conditions that do not permit safe application of the rTMS protocol used in this study.

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a.
Participation in Multiple Protocols
Subjects may be part of other protocols, including neuroimaging protocols, and this
would not be expected to interfere with our protocol. However, we plan to specifically
inquire with subjects as to their involvement in other research protocols as to best
safeguard the both the subject's welfare and the integrity of data
collected by us and other research groups.
b.
Payments to Participants
Participants will not be compensated for study screening. Participants will receive a
maximum of $250 for all baseline and treatment phase and post-assessment study
procedures. If participants do not complete all baseline or post-treatment visit
procedures, they will receive a pro-rated amount based on how many procedures were
completed. In addition, participants can receive up to $50 for completing all assessment
phone calls during the follow-up phase of the study. In total, the maximum payment
that can be received for all phases of the study is $300 ($75 for pre-assessment, $100
for the treatment phase, $75 for the post-assessment phase, and $50 for the follow-up
phase).
The mechanism of payment will adhere to the VA mandated procedure: payment form,
which the participant can obtain cash or check at the VA Palo Alto upon completion of
Baseline and Post-treatment Visit. This rate of compensation is commensurate with
other AUD research being conducted at the VAPAHCS and the payment mechanism is
used by other alcohol/substance abuse research currently conducted at the VA Palo
Alto. The total amount of payment is proportional to the participant's time and effort
and is intended to facilitate participation without adding undue influence.
Costs to Participants 
 No costs will be incurred by any participant. 
Planned Duration of the Study 
(i) Probable duration of study = 2.5 years.
(ii)Total time per participant:
Screening: 15 min
Baseline: 6 hours, over 1-day.
Treatment: 15 hours (Over approx 10 business days: 30 dTMS sessions, approx.
30 min each, performed 3x/day)
Post-Tx Assessment: 4 hours, over 1-day.
Follow-up assessments: 45 min (15min 3 times at 2-, 4-, and 6-months post-
study)

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Total Active Participation Time = approx. 26 hours over 6 months. 
All procedures will be conducted before or after normal ATS clinic hours, or 
during lunch break, so as not to interfere with the patient's treatment schedule. 
The project will be conducted at the VAPAHCS MIRECC Palo Alto Division, which 
is on the same campus as the FOR program. 
(iii). Analysis of participant data will be ongoing. 
RISKS 
Potential Risks 
i.
Risks of the Investigational devices.
Transcranial magnetic stimulation (TMS) device: TMS is regarded as safe and
without lasting side effects when established guidelines are followed. The
primary safety concern associated with any form of transcranial magnetic
stimulation procedures are seizures, however, the estimated prevalence is
very low at < 1. In the case of transcranial magnetic stimulation-seizures, all
have occurred during stimulation, there was no recurrence of seizures, and
no incidences of status epilepticus. All the reported seizures resolved
promptly after removal of stimulation, without medical intervention and
were not associated with lasting adverse effects. In those rare seizure cases,
the motor cortex was typically being stimulated; in the proposed study a
non-primary motor region, dACC, is the stimulation site. There have been no
significant adverse cognitive, brain structural, neurologic or cardiovascular
sequelae reported because of TMS. Participants treated with rTMS may
experience temporary discomfort at the site of stimulation due to
depolarization of sensory and motor neurons in the scalp under the point of
stimulation. Muscle tension headache may result in some participants
estimated to occur in less than 10% of sessions, and can persist for 1-2 hours
post stimulation. rTMS treatment can result in mild to moderate headaches
in approximately 15% of participants. These headaches are never disabling or
persistent and usually respond to ibuprofen or acetaminophen. The
incidence of headaches in those with serial transcranial magnetic stimulation
typically diminishes with increasing number of sessions. In some people,
particularly those with a history of a history of Bipolar Disorder I or II, daily
transcranial magnetic stimulation caused them to experience mania
increased energy, no need for sleep, and racing thoughts; this study will
exclude for current cyclothymia and Bipolar Disorders.

June 28, 2022 
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Magnetic Resonance Neuroimaging: The magnetic resonance scanning 
devices (3T Ultra-High Performance (UHP) system) used in scanning at the 
Stanford Center for Cognitive and Neurobiological Imaging (CNI) poses a non-
significant risk to subjects in line with the criteria for exception from an IDE, 
and routinely used by many other investigators at Stanford. There have been 
no serious adverse events incurred during scanning at the Stanford 
CNI.Source: eProtocol Section 9a (box 1) 
ii.
Investigational drugs-N/A
iii.
Commercially available drugs, biologics, reagents or chemicals-N/A
iv.
Procedures
Psychiatric and Alcohol/Drug Assessments and Questionnaires. Answering 
questions about one's psychiatric history can cause feelings of anxiety or mild 
psychological stress. 
rTMS risks are described above in 9 .i. Investigational devices. Magnetic 
Resonance Neuroimaging risks are described above in 9. i. Investigational device. 
v.
Radioisotopes/radiation-producing machines-N/A
vi.
Physical well-being
See above devices and procedures. No other risks to physical well-being are
anticipated.
vii.
Psychological well-being
Screening, psychiatric interviews, and questionnaires: The screening interview 
and psychiatric assessments, as well as self-report questionnaires, may be 
fatiguing and/or distressing for some individuals. Study participants will be 
informed that they are free to decline to answer any questions or to stop the 
assessments at any time. Psychiatric interview sessions will include breaks. In the 
event that a study participant appears to be under undue strain, the test or 
interview session will be discontinued.  
viii.
Economic well-being
No risks to economic well-being are anticipated.
ix.
Social well-being
No risks to social well-being are anticipated.
x.
Overall evaluation of risk

June 28, 2022 
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Low - innocuous procedures such as phlebotomy, urine or stool collection, no 
therapeutic agent, or safe therapeutic agent such as the use of an FDA approved 
drug or device.  
c.
International Research Risk Procedures- N/A
d.
Procedures to Minimize Risk
Screening, psychiatric interviews, and questionnaires: Participants will be
informed that these procedures may be fatiguing and/or distressing for some
individuals. Study participants will be informed that they are free to decline to
answer any questions or to stop the assessments at any time. Psychiatric
interview sessions will include breaks. In the event that a study participant
appears to be under undue strain, the test or interview session will be
discontinued. Participants will be reminded that they are free to withdraw from
participation at any time.
rTMS administration: The rTMS operator will be fully trained and qualified to 
administer the procedure according to current safety practices and standards of 
care. Co-Is Dr. Madore and Dr. Durazzo have full rTMS training and, together 
with physician Co-Is also trained in rTMS, closely monitor the rTMS operator for 
adherence to safety protocols and rTMS administration for this proposal. 
Additionally, PI Padula will obtain full rTMS training and be available as an 
additional monitor and resource to the rTMS operator. The protocol employs all 
current established and standard rTMS treatment safety and monitoring for 
adverse events guidelines. The rTMS operator will monitor all participants for ear 
protection, coil placement, and seizure activity during all sessions. 
All participants will be required to have abstained from alcohol or non-
prescribed medication for 7 consecutive days prior to the first rTMS session. 
Prior to the first rTMS session, participants will be administered the CIWA- Ar 
and must score <8 (scores >8 are indicative of potential autonomic instability); 
participants with a score >8 will immediately be escorted to VAPAHCS ATS or 
further evaluation. Participants will be randomly screened x6 for alcohol (breath 
alcohol) and substance use (urine toxicology) prior to rTMS sessions during the 
2-week treatment phase. If a participant tests positive or reports any alcohol or
substance use during the 2-week rTMS treatment period, they will be
immediately withdrawn from the study. Additionally, participants will be given
the C-SSRS prior to each rTMS session to assess for current suicide risk. Although
patients in the VAPAHCS are regularly screened for alcohol and substance use
and suicide risk while in treatment, we will conduct random alcohol/substance
screening and pre-rTMS session suicide risk assessment to ensure participant
welfare.
Should a headache or site of stimulation discomfort occur, these symptoms
usually readily respond to acetaminophen or ibuprofen. Any reported
painfulness typically improves over time or completely remits. If dental pain

June 28, 2022 
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occurs, study staff may be able to move the rTMS coil position or provide a bite 
block to reduce or eliminate this pain. To protect against possible hearing 
damage, participants will wear ear protection during rTMS sessions. This should 
greatly reduce the possibility of hearing loss. Hearing acuity testing pre-and-post 
rTMS is no longer a standard practice, given the remote likelihood of rTMS-
related hearing loss. 
Screening, Baseline and Treatment Phase: In the unlikely event that a seizure 
does occur, participants will be closely monitored and treated for any medical or 
psychological consequences. rTMS sessions will be conducted at the VAPAHCS 
MIRECC, which fully equipped to safely handle a seizure. If at any point 
during study participation, a participant has a seizure, the participant will be 
withdrawn from the study immediately although they will still be followed for 
protocol assessments. All seizures will be considered serious adverse events 
(SAE) and as such, will be reported to the study PI. We will immediately suspend 
enrollment if any of the participants experience a seizure during study 
participation and request that the Data Monitoring Safety Board (DMSB) 
evaluate the SAE data, to determine if enrollment of new participants should be 
resumed without protocol changes, if protocol modifications should be made 
before resuming enrollment, or if the study should be terminated. We recognize 
that study termination or modification based on SAEs, such as seizures, 
ultimately rests with the DMSB and the study PI. If a participant expresses 
suicidal ideation/intent and is determined to be a risk to self, a clinical evaluation 
will be immediately conducted by the PI (a licensed clinical psychologist), Co-Is 
(two licensed clinical psychologists and a board-certified psychiatrist), or by the 
participant's individual mental health provider, and/or a mental health 
emergency clinician. The participant will remain with qualified study personnel 
or a MIRECC clinician until the evaluation has been completed and a decision 
made about disposition in conjunction with the Chief of Mental Health 
Outpatient Clinic or the emergency mental health clinician. 
Follow-up Phase: If a participant discloses active suicidal or homicidal ideation or 
other clinically significant psychiatric symptomatology during the follow-up 
phase of the study, they will be provided with a warm hand off to the Veterans 
Crisis Hotline or they will be encouraged to present to a local hospital emergency 
department. 
In the event of a seizure or other medical issues possibly secondary to rTMS, the 
participant will be requested to immediate contact their primary health care 
provider. In the event of disclosure of the above psychiatric emergencies or a 
seizure, the PI or psychiatrist Co-Investigator will also be immediately notified 
and will contact the participant for further assessment and determine the 
appropriate intervention. If a participant discloses that they relapsed during the 

June 28, 2022 
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follow-up period, they will be encouraged to recontact VAPAHCS Addiction 
Treatment Services for re-evaluation and possible re-engagement in treatment. 
Magnetic Resonance (MR)Studies: Participants will be informed of risks, using 
the text provided and required by Stanford University's Institutional Review 
Board the VA. Our Research Assistants (RA) have been trained by the PI, Co-Is 
carefully pre-screen each participant for MRI safety before the MRI 
appointment. RAs also have been certified to independently operate the CNI 
magnetic resonance scanner by qualified CNI personnel. Minimal risks are 
associated with MR scanning and 3T MR scanners are now routinely used in 
clinical practice. Study participants who have metal implants, cardiac 
pacemakers, metal fragments or a known tendency for claustrophobia will not 
be admitted to the study. Study participants will be scanned with a metal 
detector before entering the 3T scanner room, and all metal objects will be 
removed. There is a remote possibility that the magnet will attract a metal 
object, producing physical injury. To make certain such event do not occur, the 
door to the magnet room is closed and there is a metal detector outside the 
door to ensure no ferromagnetic metals are allowed into the scanner. One 
theoretical hazard of the experiments is heating of the body due to radio waves, 
but the machine has several safety devices to prevent such an occurrence. There 
is also a slight risk of nerve stimulation during a portion of the procedure. While 
there are safety devices that prevent such events, this can occur in rare cases. To 
reduce this risk, volunteers will be instructed to avoid skin-to-skin contact 
between their extremities, such as clasping their bare hands or crossing their 
bare feet. In any case, such sensation is temporary and harmless. Fatigue, 
boredom, feelings of claustrophobia, or discomfort due to loud banging sounds 
of gradient coils may accompany the MR procedures. Earplugs and supplied MR-
safe headphones will be used during MR scanning. A communication system is 
set up inside each scanner so that study participants can contact the researchers 
at any time, and will be immediately removed from the scanner upon request. In 
case of adverse effects, medical intervention can be provided by Stanford 
Emergency Department staff. Study physicians will be available in the case of an 
adverse event to debrief with the participant. 
Identification of clinically significant psychiatric symptomatology other than 
suicidal ideation or plan: Although unlikely, it is possible that during the 
screening process, on the psychiatric interview and questionnaires or during 
other study procedures, participants may manifest or disclose clinically 
significant psychiatric symptoms (e.g., homicidal ideation, hallucinations) that 
were not previously identified/diagnosed by VAPAHCS Addiction Treatment 
Services staff. In this case, the participant will be immediately assessed by the PI 
or Co-I or Foundations of Recovery treatment staff (licensed clinical 
psychologist), the participant's individual mental health provider, or a mental 
health emergency clinician. The participant will not be left alone until the 

June 28, 2022 
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evaluation has been completed and a decision made about disposition in 
conjunction with the Chief of Mental Health Outpatient Clinic, or the emergency 
mental health clinician. If a participant discloses that they relapsed during the 
follow-up period, they will be encouraged to recontact VAPAHCS Addiction 
Treatment Services for re-evaluation and possible re-engagement in treatment. 
Loss of confidentiality: Every precaution will be taken to minimize loss of 
confidentiality. A triple lock system will be maintained: within a locked lab, 
locked office, and locked file cabinet. All electronic data will be secured on an 
encrypted, password-protected database behind a VA or Stanford RedCap 
firewall. The participant's name will not be used in any reports or publications 
resulting from this study. The participant's name will not be recorded on test 
material or other research records. An identification code will be used instead. 
The participant's identification code will be kept in a secured database. The PI 
and trained and qualified research team members will have access to the 
participant's information. The coded, de-identified data for each participant, 
which has been stripped of any information that could be used to identify the 
participant, may be shared with consultants. However, the participant's personal 
health information cannot be used for additional research without additional 
approval from either the participant or a review committee. 
Adverse Events (AEs) and Adverse Device Effects (ADEs): 
Definitions: 
An Adverse Event (AE) is defined by the ICH for Clinical Safety Data as any 
untoward physical or psychological occurrence in a human subject participating 
in research. The AE does not necessarily have to have a causal relationship with 
the pharmacological product, study intervention, or assessment. An AE can, 
therefore, be any unfavorable or unintended sign including an abnormal 
laboratory finding, symptom or disease associated with the use of a medicinal 
investigational product. 
An Adverse Device Effect (ADE)is defined by 21 CFR 812.3s as any adverse 
effect/event caused by or associated with the use of a device. 
Reporting: In this study, all ADEs and AEs that occur during the acute treatment 
and follow-up phases will be collected and followed until resolution or the 
individual's participation in the study ends. All events will be recorded on the 
appropriate case report form. "Relatedness" involves an assessment of the 
degree of causality between the study intervention and the event. PIs will be 
asked to provide an assessment of relatedness. The assessment provided by the 
PI is part of the information used by the sponsor to determine if the adverse 
event or effect presents a participant safety concern. An ADE is deemed to be 

June 28, 2022 
Page 20 of 25 
associated with the use of the study device if there is a reasonable possibility 
that the experience may have been caused by the device or by participation in 
the trial. Thus, all adverse events or effects with a reasonable causal relationship 
to the rTMS treatment should be considered related. A definite relationship does 
not need to be established. The following levels of relatedness will be used in 
this study: 
•Not attributed to TMS treatment
•Possibly attributed to the TMS treatment
•Attributed to the TMS treatment
Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) 
Definitions: 
Serious Adverse Events (SAEs) are a subset of adverse events and are defined by 
the ICH for Clinical Safety Data Management as any untoward medical 
occurrence that: 
•Results in death
•Is life-threatening
•Requires inpatient hospitalization or prolongation of existing hospitalization
•Results in persistent or significant disability or incapacity
•Is a congenital anomaly/birth defect or
•Any other condition that, based upon medical judgment, may jeopardize the
subject and require medical or surgical treatment to prevent one of the above
outcomes.
An Unanticipated Adverse Device Effect UADE is defined as any serious adverse 
effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or 
application, or any other unanticipated serious problem associated with a device 
that relates to the rights, safety or welfare of participants. For this study an 
UADE is considered a category of SAE, which will be reported on the same form. 
Collection and Recording: For this study, all SAEs and UADEs will be recorded on 
the SAE form, regardless of cause. The PI will be 
asked to determine whether the serious adverse event is related to: 
•rTMS device
•rTMS treatment
•Medications used to treat AUD and/or co-occurring conditions

June 28, 2022 
Page 21 of 25 
Collecting and recording SAEs/UADEs will begin at randomization and will 
continue throughout the follow-up phase. For a participant who ends study 
participation prior to the study's completion date, unresolved SAEs will be 
monitored and reported for 30 days after the End of Study date for that 
participant. In addition, the investigator must collect all SAEs reported to them 
for a period of 30 days after the study's completion. 
Expedited Reporting of Serious Adverse Events SAEs and Unanticipated Adverse 
Device Effects UADEs: Study personnel will be responsible for initially evaluating 
all serious adverse events for participant safety concerns and will confer with the 
PI as required during this evaluation process. After being reviewed by the PI, any 
event deemed to be related, serious and unexpected will be reported to study 
investigators. 
Expedited Reporting by the Sponsor to the FDA: PI will review the SAE report to 
assess completeness of documentation and to determine whether the SAE 
requires expedited reporting to the FDA. Specifically, if an event meets the 
criteria for unexpectedness (i.e., not previously reported and seriousness it will 
be reported as required by regulation to the FDA within 10 working days for 
UADEs and within 7 calendar days for unexpected SAEs. Safety Reports of the 
sponsor receiving the report as required by regulation. 
Data Monitoring Safety Board (DMSB): Reporting of Adverse Events, Adverse 
Device Effects, Serious Adverse Events, and Unanticipated Adverse Device 
Effects. Study Personnel will generate tabulations of AEs and SAEs and present a 
summary of these to the DMSB on a schedule set by the DMSB. The DMSB will 
also determine when they should be unblinded to treatment assignment for the 
reviewing of adverse event data. The DMSB will advise the PI concerning 
whether the study should continue or be stopped for safety reasons. 
Communication among the Investigative Team: The PI will have a weekly group 
lab meeting with all RAs. Additionally, the VAPAHCS MIRECC has weekly PI 
meetings to discuss issues relevant to ongoing MIRECC research projects. All key 
VA Co-Is associated with this project attend these weekly meetings. 
Study Conclusion 
The experiment will end at either the normal termination or whenever the subject decides to 
withdraw from the study. Participants will be asked to complete the brief monthly in-person or 
telephone assessments as described in the follow-up phase. In the event that an interim 
analysis demonstrates futility, the PI, or Co-Is will determine unacceptable level of risk, 
regulatory agencies mandate discontinuation of the study, or a product recall occurs that 
necessitates stopping the study, any planned rTMS treatments will be immediately 
discontinued. 

June 28, 2022 
Page 22 of 25 
e.
Data Safety Monitoring Plan (DSMC)
i.
Data and/or events subject to review
ii.
Although this study protocol is low risk, and will enroll a modest number of
participants, we will create a DSMB as we believe this is consistent with best
clinical practices. Types of data and events that will be reviewed are: 1)
Aggregate Data Analysis Reports; 2) Progress toward Study endpoints; 3)AEs,
SAEs and unanticipated problems; 4) Protocol deviations.Person(s) responsible
for Data and Safety Monitoring
The Protocol Director will be the only monitoring entity for this study.
iii.
Frequency of DSMB meetings-N/A
iv.
Specific triggers or stopping rules
In order to have sufficient power to evaluate the primary hypotheses of
this study, it is expected to continue until all participants have completed the
procedures and follow-up assessments.
v.
DSMB Reporting
All SAEs will be reported within 24 hours of learning of the SAE.
Unanticipated problems involving risks to participants or others will be
reported within 5 days.
vi.
Will the Protocol Director be the only monitoring entity?
YES
vii.
Will a board, committee, or safety monitor be responsible for study monitoring?
NO
f.
Risks to Special Populations
N/A
3.
BENEFITS
dTMS could potentially generate substantial health benefits for VHA patients. Deep TMS may 
offer a viable and more efficacious treatment option for Veterans with AUD. For these reasons, 
the anticipated risks are reasonable in relation to the anticipated benefits to study participants. 
If this preliminary study proves feasible, acceptable, and beneficial, then it will serve as the 
basis for a larger mechanistic study and subsequent clinical trial. The VISN-21 MIRECC has 
funded a roll-out for TMS for depression concurrent with the conclusion of CSP 556 "The 
Effectiveness of rTMS in Depressed VA Patients." Thus, the findings and protocol for our deep 

June 28, 2022
Page 23 of 25 
TMS intervention for AUD can be readily disseminated to VA and non-VA researchers, clinicians, 
and leadership through the MIRECC EBP program. As described in this proposal, TMS is a very 
safe treatment when standard safety protocols are followed. 
4.
PRIVACY AND CONFIDENTIALITY
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health. 
Most medical research must comply with the Health Insurance Portability and 
Accountability Act (HIPAA) regulations if it uses protected health information (PHI). See 
more information on HIPAA. 
PHI is health information with one or more of the following identifiers: 
1. Names
2. Social Security numbers
3. Telephone numbers
4. All geographic subdivisions smaller than a State, including street address, city,
county, precinct, zip code, and their equivalent geocodes, except for the initial
three digits of a zip code, if, according to the current publicly available data
from the Bureau of the Census: (1) The geographic unit formed by combing all
zip codes with the same three initial digits contains more than 20,000 people;
and (2) The initial three digits of a zip code for all such geographic units
containing 20,000 or fewer people is changed to 000s
5. All elements of dates (except year) for dates directly related to an individual,
including birth date, admission date, discharge date, date of death; and all ages
over 89 and all elements of dates (including year) indicative of such age, except
that such ages and elements may be aggregated into a single category of age 90
or older
6. Fax numbers
7. Electronic mail addresses
8. Medical record numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers, including license plate numbers
13. Device identifiers and serial numbers
14. Web Universal Resource Locations (URLs).
15. Internet Protocol (IP) address numbers
16. Biometric identifiers, including finger and voice prints
17. Full face photographic images and any comparable images; and
18. Any other unique identifying number, charactristic, or code (except the unique
code assigned by the Investigator(s) to code the research data, unless the code
was derived from other identifiable information, such as the SSN).

June 28, 2022 
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During the consenting process, in-person screening, and the collection 
of other study data, participants will meet in a private interview room with a member of the 
study team at the study site Bldg. 5 at VAPAHCS). 
We will collect the following HIPAA identifiers, as mentioned on the VA HIPAA form: 
- Social security number for participation compensation i.e., participant payment, and entry of
required research notes into VA medical records;
- Name, address and telephone number for follow-up assessments and to
mail participation compensation; and to mail payment;
- Birth dates & visit dates.
We will collect the following PHI, as mentioned on the HIPAA: 
- Demographic information including age and race/ethnicity;
- Results of past routine laboratory tests;
- Physical examinations and related past medical records;
- Magnetic resonance neuroimaging data, MRI digital images and clinical reads of MRIs;
- Research data, questionnaires, and study progress notes, which may include: cognitive test
scores; questionnaires about mood and everyday function; current and past medical history;
current and past medications; adverse effects during the study; and height and weight.
Paper data with PHI will be kept in locked file cabinets in locked offices. Data collected on paper 
forms and questionnaires will be entered into encrypted, password-protected databases. 
Electronic files and databases are maintained on a secure VA network, on a server that is 
backed up and located in a secure server room accessible only by authorized personnel. Only 
staff listed for a given protocol are granted access to appropriate server folders. Staff's 
computers are password-protected, encrypted, and backed up. The VA prohibits removable 
drives. 
At the VA, REDCap data are transmitted from behind the VA firewall (on the VA intranet) and 
REDCap servers are housed at the VA Informatics and Computing Infrastructure (VINCI). VINCI 
servers are physically located at the VA Austin Information Technology Center (AITC), located in 
Austin, Texas. VA REDCap is only available to VA researchers through a web URL that requires a 
VA generated login and email address. Each subject will be assigned a participant ID number 
(PID). All computer-entered data will be coded using PIDs only. All personnel involved in this 
study will have successfully completed applicable VA and Stanford training. All subject-level 
identifiable data will be treated as Protected Health Information (PHI) unless that data does 
NOT contain any of the data elements that HIPAA considers protected. Any data, specimens, 
forms, reports, and other records that leave the site will be identified only by a participant id 
number (PID) to maintain confidentiality. Information will not be released without written 
permission of the participant, except as necessary for monitoring by the IRB. 
Data will be labeled by a participant ID number (PID). Information linking the PID code and PHI 
will be kept on a secure, password protected computer behind a firewall. The Data Manager is 
responsible for de-identification of data. 

June 28, 2022 
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Members of the research team will have access to all data. If the participant requests explicitly 
in writing, we will send information about clinical results to his/her the medical or mental 
health care provider of their choice. De-identified study data may be shared with collaborating 
researchers at Stanford University and at other institutions. De-identified data may also be 
shared with collaborating researchers at other institutions in the future. 
A participant ID number PID is assigned to a subject after they sign a consent form. This 
numeric code is independent of any identifying information. 
No PHI will be transferred to any person/organization outside of the or VA research team. 
All research staff will complete and remain current with all required VA and Stanford training 
prior to working with human subjects. The PI, along with VA Research Administration, also 
reinforce the importance of maintaining confidentiality.