~0 spots leftby Nov 2025

rTMS for AUD+mTBI

(TMS_AUD+mTBI Trial)

AA
Overseen byAmy 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

AA

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.
See 3 more

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.
See 10 more

Treatment Details

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) (Non-invasive Brain Stimulation)
Trial OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: activeActive Control1 Intervention
active rTMS
Group II: placeboPlacebo Group1 Intervention
placebo rTMS

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

๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as rTMS for:
  • Depression
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as rTMS for:
  • Depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+