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Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury

RecruitingPhase 1Ages 22 Years - 65 YearsAllVA Office of Research and Development
NCT05647044 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, bu

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📋 Eligibility rules (as published)
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
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What it tests

  • intermittent theta burst stimulation
  • placebo intermittent theta burst stimulation
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Where

1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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