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
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
February 5, 2026
February 1, 2026
2.3 years
October 16, 2024
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of Phosphatidylethanol (PEth) level
Determine if accelerated IR-TMS significantly changes alcohol consumption (as measured by phosphatidylethanol (PEth)) in participants with AUD.
Baseline, 1 month and 6 months
Secondary Outcomes (1)
Brain functional connectivity
Baseline to 6 months
Study Arms (3)
Left dorsolateral prefrontal cortex (L-DLPFC) IR-TMS
ACTIVE COMPARATORStimulation 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.
Dorsomedial prefrontal cortex (DMPFC) IR-TMS
ACTIVE COMPARATORStimulation 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.
Orbitofrontal cortex (OFC) IR-TMS
ACTIVE COMPARATORStimulation 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.
Interventions
TMS applies a strong (\~2 Tesla), rapidly changing electro-magnetic field at the scalp to induce electrical current flow in underlying brain tissues
Eligibility Criteria
You may qualify if:
- Two self-reported heavy drinking episodes (\>4 drinks for men, \>3 for women) or \>13 drinks in the last 14 days (at screening)
- PEth \>20 ng/mL (at baseline)
- Diagnosis of a current, moderate to severe AUD assessed by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) substance use checklist
- Able to attend all study appointments
- Fluent in English
You may not qualify if:
- Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)
- Inability to provide informed consent
- Alcohol withdrawal-related seizure or hospitalization in the prior 12 months
- Currently enrolled in AUD treatment
- Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder
- Any history or signs of serious medical or neurological illness including seizure disorders
- History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
- Liver enzymes that are more than 5x the normal range
- Females will be excluded if they are pregnant
- Any history or signs of metal objects in the body deemed unsafe for Magnetic Resonance Imaging (MRI) or that may adversely affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers, metal implants, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brett C Ginsburg, PhD
The University of Texas Health Science Center at San Antonio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 18, 2024
Study Start
February 3, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the time of study completion and publication in a peer review journal
Final copies of all publications, abstracts, and presentations will be archived in the study's repository and made accessible to all study personnel, including the submitted version and any subsequent revisions. Public policy will focus on ensuring that all dissemination of research findings from this study is conducted in an accurate, transparent and ethical manner.