Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Last updated: August 7, 2025
Sponsor: VA Palo Alto Health Care System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Addictions

Alcohol Dependence

Substance Abuse

Treatment

Active Transcranial Magnetic Simulation

Sham

Clinical Study ID

NCT06415721
PADNEW_0003
  • Ages 25-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toparticipating in any study-specific procedures or assessments.

  • If on a medication regimen, that regimen will be stable for the duration of thestudy;

  • Fluency in English.

Exclusion

Exclusion Criteria:

  • Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI)contraindications: such as a cardiac pacemaker, cochlear implant, or an implanteddevice (deep brain stimulation, metal in the head, metal in the body,claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected inthe head and body within 30 cm of the treatment coil.

  • General medical condition, disease or neurological disorder that interferes with theassessments or participation.

  • Unable to safely withdraw, at least two weeks prior to treatment, from medicationsthat increase seizure risk.

  • Current substance abuse (except caffeine or nicotine) as determined by positivetoxicology screen.

  • Have a mass lesion, cerebral infarct, or other active CNS disease, including analcohol-related seizure or a seizure disorder. • A recent suicide attempt (definedas within the last 30 days) or presence of current suicidal plan or intent. Patientsat risk for suicide will be required to establish a written safety plan involvingtheir primary therapist before entering the study.

  • Severe impediment to vision, hearing and/or hand movement, likely to interfere withthe 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 alterseizure threshold

  • unstable chronic illness.

  • Current or lifetime history of bipolar disorder or psychosis.

  • Participation in another concurrent intervention based clinical trial.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Active Transcranial Magnetic Simulation
Phase:
Study Start date:
August 25, 2025
Estimated Completion Date:
January 01, 2026

Study Description

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. Transcanial Magnetic Stimulation (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. To date, TMS has been primarily delivered to the dorsolateral and medial prefrontal cortices as these regions are, on average, highly reactive to alcohol cues. On an individual basis, however, peak brain response to alcohol cues can vary substantially in spatial location within the brain. Retrospective analyses of TMS-AUD clinical trails has demonstrated that when TMS is delivered to an individual's peak brain response to alcohol cues, the likelihood of remaining abstinent is increased by a factor of 5.6 (relative to sham TMS treatment). This study aims to deliver one session of TMS to a cortical target which displays peak functional connectivity to the ventral striatum, a key brain region mediating reward and alcohol cue reactivity. The ultimate goal of this study evaluate change in brain reactivity to alcohol cues following active and sham TMS.

Connect with a study center

  • VA Palo Alto Health Care System

    Palo Alto, California 94304
    United States

    Active - Recruiting

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