Recruiting

Deep TMS

Sponsor:

Stanford University

Code:

NCT06949423

Conditions

Alcohol Use Disorder (AUD)

Transcranial Magnetic Stimilation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active

Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.

Conditions

Alcohol Use Disorder (AUD)

Transcranial Magnetic Stimilation

Study ID

NCT06949423

Start date

Dec 17, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-75.
  • Current DSM-5 diagnosis of moderate to severe AUD (\≥4 diagnostic symptoms).
  • Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
  • Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
  • Able to read, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.
  • If on a medication regimen for comorbid symptoms, that regimen will be stable for the duration of the study and patient will be willing to remain on this regimen during the treatment phase.
  • Fluency in English.

Exclusion Criteria:

  • Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.
  • General medical condition, disease or neurological disorder that interferes with the assessments or participation.
  • Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.
  • Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.
  • Have a mass lesion, cerebral infarct, or other active CNS disease, including an alcohol-related seizure or a seizure disorder.
  • A recent suicide attempt (defined as within the last 30 days) or presence of current suicidal plan or intent. Patients at risk for suicide will be required to establish a written safety plan involving their primary therapist before entering the study.
  • Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols.
  • Greater than mild traumatic brain injury (defined as greater than 10 minutes loss of consciousness).
  • Taking benzodiazepine or neuroleptic medications, or any medication known to alter seizure threshold
  • Acute or unstable chronic illness.
  • Current or lifetime history of bipolar disorder or psychosis

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active dTMS

Participants will receive 30 sessions of active-dTMS to the dACC/mPFC with the H7 coil, administered 3 times per day over 10 consecutive business days. Each treatment visit will last approximately 30 minutes in total.

sham comparator: Sham dTMS

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

Interventions

Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active

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

Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham

The study will utilize an identical protocol using the H7 coil to administer a sham condition.

Primary outcome measure

  • Change in Dorsal Anterior Cingulate Cortex Function (dACC) Activation During the FACES Task, Measured via fMRI [ Time Frame: 1-4 days post treatment ]
  • Percentage of Days Abstinent from Alcohol, Assessed by Timeline Followback (TLFB) [ Time Frame: 3-months post treatment ]
  • Percentage of Heavy Drinking Days, Assessed by Timeline Followback (TLFB) [ Time Frame: 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Samantha J Ward, BS

650-493-5000samward@stanford.edu

Eileen G Fischer, BS

210-993-2065grace.fischer@stanford.edu

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Eileen G Fischer, BS

210-993-2065grace.fischer@stanford.edu

Principal Investigator:

Claudia B Padula, PhD

More Information

Sponsor

Stanford University

Last update posted

May 15, 2026

Last verified

Feb, 2026

Keywords

  • Veterans
  • Deep Transcranial Magnetic Stimulation (dTMS)
  • Neuroimaging
  • Relapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-15.