Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder

NCT04927364 | Completed Results FDA Device

• 1 other identifier: 54988
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with an alcohol use disorder (AUD).

Conditions

Alcohol Use Disorder (AUD); Transcranial Magnetic Stimulation

Keywords

Veterans; Deep Transcranial Magnetic Stimulation (dTMS); Alcohol Use Disorder; Neuroimaging; Relapse

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Relapse to Alcohol 6 Months After Treatment

  Six months after completing the intervention, participants will be contacted to determine self-reported relapse status. To determine relapse status, participants complete brief standardized measures of alcohol and substance use, Alcohol Timeline Followback (TLFB) and the Brief Addiction Monitor (BAM) questionnaire.

  6 months

• Percentage of Days Abstinent

  Abstinence defined as no drinks consumed.

  6 months

• Percentage of Days of Heavy Drinking

  Heavy drinking is defined as consuming (in a 24 hour period) 3 or more drinks for women, or 4 or more drinks for men.

  6 months

Study Arms (1)

Active dTMS

EXPERIMENTAL

Participants will receive 30 dTMS treatments, administered 3 times per day over 10 consecutive business days, Each treatment visit will last approximately 30 minutes in total.

Device: Deep Transcranial Magnetic Stimulation (dTMS) H7 coil

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H7 coil DEVICE

The study will utilize the H7 coil to administer Deep Transcranial Magnetic Stimulation (dTMS) to the dorsal anterior cingulate cortex (dACC), a core salience network node.

Active dTMS

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for AUD, and alcohol is self-identified as the 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.

You may not qualify if:

• Psychiatric:
• Current diagnosis of Schizophrenia Spectrum Disorders and Bipolar Disorders;
• 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 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• Koob GF, Volkow ND. Neurocircuitry of addiction. Neuropsychopharmacology. 2010 Jan;35(1):217-38. doi: 10.1038/npp.2009.110.

  PMID: 19710631 BACKGROUND

• Peters SK, Dunlop K, Downar J. Cortico-Striatal-Thalamic Loop Circuits of the Salience Network: A Central Pathway in Psychiatric Disease and Treatment. Front Syst Neurosci. 2016 Dec 27;10:104. doi: 10.3389/fnsys.2016.00104. eCollection 2016.

  PMID: 28082874 BACKGROUND

• Harel M, Perini I, Kampe R, Alyagon U, Shalev H, Besser I, Sommer WH, Heilig M, Zangen A. Repetitive Transcranial Magnetic Stimulation in Alcohol Dependence: A Randomized, Double-Blind, Sham-Controlled Proof-of-Concept Trial Targeting the Medial Prefrontal and Anterior Cingulate Cortices. Biol Psychiatry. 2022 Jun 15;91(12):1061-1069. doi: 10.1016/j.biopsych.2021.11.020. Epub 2021 Dec 6.

  PMID: 35067356 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Recurrence

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Claudia Padula
• Organization: VA Palo Alto Healthcare System

padula@stanford.edu

650-849-1211

Study Officials

• Claudia Padula, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Michelle Madore, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Timothy Durazzo, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Research Science Specialist

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 16, 2021
• Study Start: September 6, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: December 29, 2025
• Results First Posted: July 10, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Three to twelve months after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)