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

NCT ID: NCT06648642

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2027-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS)

Eligibility Criteria

Inclusion Criteria

1. Two self-reported heavy drinking episodes (>4 drinks for men, >3 for women) or >13 drinks in the last 14 days (at screening)

2. PEth >20 ng/mL (at baseline)

3. 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

4. Able to attend all study appointments

5. Fluent in English

Exclusion Criteria

1. Current diagnosis of a moderate or severe substance use disorder (SUD; other than AUD, cannabis, or nicotine)

2. Inability to provide informed consent

3. Alcohol withdrawal-related seizure or hospitalization in the prior 12 months

4. Currently enrolled in AUD treatment

5. Psychiatrically or medically unsafe to participate due to a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder

6. Any history or signs of serious medical or neurological illness including seizure disorders

7. History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more

8. Liver enzymes that are more than 5x the normal range

9. Females will be excluded if they are pregnant

10. 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellcome Leap Inc.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Brett Ginsburg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett C Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

Be Well Institute, University of Texas Health Science Center - Department of Psychiatry & Behavioral Sciences

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brett C Ginsburg, PhD

Role: CONTACT

ginsburg@uthscsa.edu

210-567-0871

Tara Wright, PhD, MS

Role: CONTACT

wrightt3@uthscsa.edu

210-450-3903

Facility Contacts

Brett C Ginsburg, PhD

Role: primary

ginsburg@uthscsa.edu

210-567-0871

Tara Wright, PhD, MS

Role: backup

WrightT3@uthscsa.edu

210-450-3909

Other Identifiers

STUDY00000467

Identifier Type: -

Identifier Source: org_study_id