iTBS for Concussion-Related Impulsivity and Suicidal Thoughts

Phase 1

Recruiting

Led By Alexandra L Aaronson, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.

Summary

This trial studies a new treatment for impulsivity, suicidal thoughts, and functional impairments after a mild traumatic brain injury. Researchers use a high-powered magnetic pulse, called iTBS, to activate certain cells in the brain to try and improve symptoms.

Who is the study for?

This trial is for veterans aged 22-65 with mild traumatic brain injury (mTBI) who experience impulsivity and suicidal thoughts. Participants must have a history of impulsivity or score high on an urgency scale, and have had recent suicidal ideation. They cannot join if they have epilepsy, MRI contraindications like claustrophobia or metal implants, severe TBI history, unstable medical conditions, recent major surgery, pregnancy, active substance abuse issues, non-traumatic neuroinjury history or current psychosis.

What is being tested?

The study tests intermittent theta burst stimulation (iTBS), which uses magnetic pulses to activate brain cells in hopes of improving symptoms from mTBI such as impulsivity and suicidal thoughts. While iTBS is FDA approved for other uses, it's not yet approved for these specific symptoms when applied to the front of the head.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort at the stimulation site or headaches due to magnetic pulse exposure. Since iTBS involves brain cell activation there could be risks related to changes in mood or cognition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins

This trial's timeline: 3 weeks for screening, Varies for treatment, and rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins for reporting.