Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Mild Traumatic Brain Injury, Suicidal Ideation, Impulsivity
In brief
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.
Key facts
- Study ID
- NCT05647044
- Run by
- VA Office of Research and Development
- People needed
- 55
- Starts
- 2024-05-20
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-04-14
Who can join
Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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