Developing Functional Connectivity-Guided TMS for Alcohol Use Disorder

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Palo Alto Health Care System
Study ID
NCT06415721
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Transcranial Magnetic Simulation — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active fMRI-guided TMS
  • Sham Comparator: Sham fMRI-guided TMS

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304
Luzille Cowlah
[email protected]
4152799462

Find similar trials in Palo Alto, CA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
VA Palo Alto Health Care System· Palo Alto, CA

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