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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up

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.