Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06648642
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    TMS applies a strong (\~2 Tesla), rapidly changing electro-magnetic field at the scalp to induce electrical current flow in underlying brain tissues

Study Details

This study is testing a new treatment called IR-TMS (image-guided, robot navigated transcranial magnetic stimulation) to see if it can help people who drink too much alcohol to reduce the amount they drink. Participants will be placed into one of three groups, each receiving a slightly different version of this treatment. The study involves going through a few sessions of IR-TMS, having brain scans (MRI), providing blood and urine samples, and answering questions about their drinking and mental health. These activities are part of the study and aren't usually part of regular treatment for alcohol use. IR-TMS is different from regular treatments like therapy or medication because it uses magnetic fields to target specific parts of the brain. The goal is to see if this treatment can help reduce the urge to drink. There are other options, like sticking with therapy or medication, which are less intense but have been used for a longer time.

Key Dates

Start date
Feb 3, 2025
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Left dorsolateral prefrontal cortex (L-DLPFC) IR-TMS
    Stimulation will be delivered to the L-DLPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.
  • Active Comparator: Dorsomedial prefrontal cortex (DMPFC) IR-TMS
    Stimulation will be delivered to either the DMPFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.
  • Active Comparator: Orbitofrontal cortex (OFC) IR-TMS
    Stimulation will be delivered to either the OFC at a depth corrected intensity of 80-95 V/m, using a theta burst stimulation protocol which delivers 1,800 pulses/session. Sessions will be compressed and delivered up to 4 times per day, over the course of 2 weeks.

Primary Outcome Measure

Measure of Phosphatidylethanol (PEth) level [ Time Frame: Baseline, 1 month and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral SciencesSan AntonioTexas78229
Brett C Ginsburg, PhD
[email protected]
210-567-0871
Tara Wright, PhD, MS
[email protected]
210-450-3909

Find similar trials in San Antonio, TX

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences· San Antonio, TX

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