NCT06648642

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

An Open-label Clinical Trial of IR-TMS for AUD and Development of a Neurobiological Biomarker for Craving and Relapse Validated Using a Direct Biochemical Biomarker (Phosphatidylethanol) of Alcohol Use

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants with AUD will undergo accelerated IR-TMS treatments and longitudinal fMRI scanning to determine treatment effects and durability. Participants will be recruited and randomized to 1 of 3 treatment target site regions: 1) Left dorsolateral prefrontal cortex; 2) Dorsomedial prefrontal cortex; or 3) Orbitofrontal Cortex. Each participant's target site region will be determined by personalized fMRI connectivity maps. Participants will receive up to 4 IR-TMS treatments per day for up to 10 days (total = 40 accelerated IR-TMS treatments) in an open-label clinical trial with an adaptive treatment design-if one target site region demonstrates superior treatment responses, the remaining participant sample will undergo IR-TMS treatments on that target site.

Conditions

• Alcohol Use Disorder

Interventions

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

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-10-18
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study