Recruiting

TMS

Sponsor:

VA Palo Alto Health Care System

Code:

NCT06415721

Conditions

Alcohol Use Disorder

Alcohol Abuse

Alcoholism

Drinking Behavior

Drinking Problem

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Magnetic Simulation

Sham

Study Details

Brief summary:

Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.

Conditions

Alcohol Use Disorder

Alcohol Abuse

Alcoholism

Drinking Behavior

Drinking Problem

Study ID

NCT06415721

Start date

Aug 25, 2025

Status verified date

Jul, 2025

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between age 25 and 75.
  • Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).
  • Able to attend scheduled clinic visits
  • Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments.
  • If on a medication regimen, that regimen will be stable for the duration of the study;
  • 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
  • unstable chronic illness.
  • Current or lifetime history of bipolar disorder or psychosis.
  • Participation in another concurrent intervention based clinical trial.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active fMRI-guided TMS

sham comparator: Sham fMRI-guided TMS

Interventions

Active Transcranial Magnetic Simulation

1 session of active continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. TMS will be delivered using the Magventure MagPro X100.

Sham

1 session of sham continuous theta burst stimulation (3600 pulses, 110% RMT) will be delivered to the cortical region demonstrating maximal functional connectivity with the striatum during alcohol cue presentation. The MagVenture MagPro x100 is capable of administering a sham stimulation. The reverse side of the TMS coil is plated with a magnetic shield such that electromagnetic energy cannot stimulate the brain. The device offers compatibility with Transcutaneous Electrical Nerve Stimulation devices such that titrated electrical pulses can be delivered to the scalp location to mimic the sensation of a TMS pulse without stimulating the brain.

Primary outcome measure

  • Change in blood-oxygen level dependent signal as a measure of change in alcohol cue reactivity [ Time Frame: Baseline (pre-TMS) and Day 2 (post-TMS) ]

Central Contacts and Locations

Central contacts

Daniel McCalley

650-493-5000mccalled@stanford.edu

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Luzille Cowlah

4152799462Luzille.cowlah@va.gov

More Information

Sponsor

VA Palo Alto Health Care System

Last update posted

Aug 13, 2025

Last verified

Jul, 2025

Keywords

  • Transcranial Magnetic Stimulation
  • Veterans
  • 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 VA Palo Alto Health Care System on 2025-08-13.