Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury (NCT05647044) | Clinical Trial Compass
RecruitingPhase 1
Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
United States55 participantsStarted 2024-05-20
Plain-language summary
The investigators hope to develop a treatment for suicidal ideation (SI), impulsivity and functional impairments (such as difficulties in social and work settings) that occur after a mild traumatic brain injury (mTBI). These conditions have been shown to be linked. The investigators are using a high-powered magnetic pulse, called intermittent theta burst stimulation (iTBS) applied to the head to see if it can improve these symptoms. The high-powered magnetic pulse causes certain cells in the brain to activate, which seems to strengthen connections between parts of the brain. The purpose of this research is to gather early information on the safety and effectiveness of iTBS provided to the front of the head for impulsivity, SI and functional deficits after mTBI. The investigators plan to use the data collected in this study to develop larger studies in the future. iTBS is FDA approved, but not for these specific symptoms, or in the specific location the investigators are placing it. The investigators are testing to see if its effective for the above conditions when applied to the front of the head.
Who can participate
Age range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 22-65 years of age
* can read and speak English
* meets criteria for mTBI according to the symptom attribution and classification (SACA) scale
* Has a C-SSRS (suicidal ideation rating) of \>1 within the past month
* Has a history of impulsivity documented in the medical chart and/or a score of \>20 on the UPPS-P negative urgency impulsivity subscale
Exclusion Criteria:
* Has contraindications to iTBS (i.e., epilepsy)
* Has contraindications to MRI (i.e., claustrophobia, ferromagnetic metal implants)
* Has an active substance use disorder per the DSM-V criteria
* Has a history of moderate to severe TBI
* Has a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)
* Has a history of, or current psychosis not due to an external cause
* Is pregnant
* Has an active, unstable medical condition
* Is within 12 weeks of a major surgery or operation
* Is within 1 year of TBI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Session Completion Rate
Timeframe: Endpoint - after last iTBS session, approximately 2 weeks
2
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Timeframe: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins