Actively Recruiting
Developing Functional Connectivity-Guided Transcranial Magnetic Stimulation for Alcohol Use Disorder
Led by VA Palo Alto Health Care System · Updated on 2025-08-13
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VA Palo Alto Health Care System
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Alcohol Use Disorder (AUD) is a major cause of preventable death and relapse rates remain high despite existing treatments. This research aims to evaluate one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a method to reduce brain reactivity to alcohol cues, which may contribute to relapse. The study focuses on delivering TMS to individual brain areas showing peak response to alcohol stimuli, with the goal of improving treatment outcomes. Participants will receive either one session of active continuous theta burst TMS or a sham version, both targeting the brain region with strongest functional connectivity to the ventral striatum. The active TMS involves 3600 pulses at 110% resting motor threshold using the Magventure MagPro X100 device. The sham treatment mimics the sensation without stimulating the brain to serve as a comparison. The study will assess brain response changes before and after TMS using fMRI. During the study, participants will undergo brain imaging and TMS sessions with monitoring of brain signals related to alcohol cue reactivity. The main measure is the change in blood-oxygen level dependent signal from baseline to the day after TMS. The study includes a randomized, quadruple-blind design and participants are monitored for safety and adherence. The total age range for participants is 25 to 75 years, and all study visits and assessments are planned according to the protocol.
CONDITIONS
Brief Title
Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between age 25 and 75.
- Current DSM-5 diagnosis of moderate to severe Alcohol Use Disorder with 4 or more diagnostic symptoms.
- Able to attend scheduled clinic visits.
- Able to read, understand, and voluntarily sign informed consent before any study procedures.
- Stable medication regimen for the duration of the study if applicable.
- Fluent in English.
You will not qualify if you...
- Contraindications to transcranial magnetic stimulation (TMS) or MRI such as cardiac pacemaker, cochlear implant, deep brain stimulation, metal in head or body, claustrophobia, pregnancy, or breastfeeding.
- General medical, neurological, or psychiatric conditions interfering with participation.
- Unable to safely stop medications that increase seizure risk at least two weeks before treatment.
- Current substance abuse (except caffeine or nicotine) confirmed by toxicology.
- History of mass lesion, cerebral infarct, active CNS disease, alcohol-related seizure, or seizure disorder.
- Recent suicide attempt within 30 days or current suicidal plan/intent without a safety plan.
- Severe vision, hearing, or hand movement impairments affecting protocol compliance.
- Greater than mild traumatic brain injury with loss of consciousness over 10 minutes.
- Use of benzodiazepine, neuroleptic, or medications altering seizure threshold.
- Unstable chronic illness.
- Current or lifetime bipolar disorder or psychosis.
- Participation in another concurrent intervention clinical trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive one session of transcranial magnetic stimulation (TMS) targeted to a brain region showing peak connectivity related to alcohol cue reactivity. This may be active or sham stimulation.
1 treatment visit (in-person) and 1 follow-up visit (in-person) on Day 2
Trial Site Locations
Total: 1 location
1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
D
Daniel McCalley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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