rTMS for AUD+mTBI

(TMS_AUD+mTBI Trial)

Overseen by Amy A Herrold, PhD BA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

Research Team

Amy A Herrold, PhD BA

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

This trial is for English-speaking Veterans aged 22-65 with alcohol use disorder (AUD) and mild traumatic brain injury or PTSD. They must pass an MRI safety screening, have specific AUDIT-C scores, and not be in severe alcohol withdrawal. Exclusions include severe TBI, psychotic disorders, seizure history, certain medication use, substance dependence other than alcohol, recent mild TBI or surgery involving the heart/brain vessels.

Inclusion Criteria

Criterion: Military veterans

I am between 22 and 65 years old.

Your CIWA-Ar score is 10 or higher.

Exclusion Criteria

You have had a moderate to severe traumatic brain injury in the past.

You have talked about wanting to hurt yourself or have tried to hurt yourself in the past 6 months.

You have been diagnosed with schizophrenia or bipolar disorder.

Treatment Details

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS) (Non-invasive Brain Stimulation)

Trial Overview The study tests repetitive Transcranial Magnetic Stimulation (rTMS) to reduce alcohol cravings in Veterans with AUD plus mTBI/PTSD. It's a randomized controlled trial where half receive real rTMS and half get placebo over two weeks (10 sessions). Follow-up calls assess craving levels post-treatment.

Participant Groups

Group I: active Active Control 1 Intervention

active rTMS

Group II: placebo Placebo Group 1 Intervention

placebo rTMS

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in Canada, Japan for the following indications:

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+