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Non-invasive Brain Stimulation

rTMS for AUD+mTBI (TMS_AUD+mTBI Trial)

Phase 2
Waitlist Available
Led By Amy A Herrold, PhD BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 22 through 65
Be older than 18 years old
Must not have
History of: surgery on blood vessels in brain and/or valves of the heart, brain hemorrhage, neurovascular conditions, neurodegenerative disorders, claustrophobia, metal in eye/face, shrapnel/bullet remnants in brain
Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up
Awards & highlights

Summary

This trial is testing whether a treatment called repetitive transcranial magnetic stimulation (rTMS) can help reduce alcohol craving in veterans with mild traumatic brain injury and/or post-traumatic stress disorder.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, common side effects of rTMS may include headache, scalp discomfort at the treatment site during stimulation sessions; rare risks involve seizures or hearing loss if ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery on my brain's blood vessels or heart valves, or have conditions like brain hemorrhage, neurovascular issues, neurodegenerative disorders, claustrophobia, metal in my eye/face, or shrapnel/bullet remnants in my brain.
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I am taking medication that could increase my risk of seizures.
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I am taking medication to help with cravings or addiction.
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I am taking medication for seizures or have had a seizure in the last 6 months.
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I have been diagnosed with congestive heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Penn Alcohol Craving Scale Change
Total Adverse Event Frequency
Total rTMS Sessions Completed

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: activeActive Control1 Intervention
active rTMS
Group II: placeboPlacebo Group1 Intervention
placebo rTMS

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,978 Total Patients Enrolled
43 Trials studying Alcoholism
6,517 Patients Enrolled for Alcoholism
Amy A Herrold, PhD BAPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
2 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Alcoholism
100 Patients Enrolled for Alcoholism

Media Library

Repetitive Transcranial Magnetic Stimulation (rTMS) (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03995173 — Phase 2
Alcoholism Research Study Groups: active, placebo
Alcoholism Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation (rTMS) Highlights & Side Effects. Trial Name: NCT03995173 — Phase 2
Repetitive Transcranial Magnetic Stimulation (rTMS) (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995173 — Phase 2
~0 spots leftby Nov 2024