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Studies

Interventional Recruiting Phase 1

NCT05647044 on ClinicalTrials.gov

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

Official title: Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-occurring Mental Health Conditions

  • Sponsor: VA Office of Research and Development
  • Enrollment: 55 (Estimated)
  • Study start: 2024-05-20 (Actual)
  • Primary completion: 2028-03-31 (Estimated)
  • Study completion: 2028-03-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Magventure MagProX 100 with MagOption stimulator and Magpro Cool Coil B 65 A/P and Magpro C-B 60
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Mild Traumatic Brain Injury
  • Suicidal Ideation
  • Impulsivity

Intervention / Treatment

  • Device: intermittent theta burst stimulation
  • Device: placebo intermittent theta burst stimulation

Primary Outcome Measures

  • Session Completion Rate (Endpoint - after last iTBS session, approximately 2 weeks)
    For establish intervention feasibility and tolerability, the study will tract the number of completed iTBS sessions and compute completion percentage rates for each participant.
  • Change in Social and Occupational Functioning Assessment Scale (SOFAS) (Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins)
    The Social and Occupational Functioning Assessment scale is a rating, given by a trained medical provider, of an individual's ability to perform basic functioning (such as hygiene, maintaining a job, having social relationships). The scale is from 10, meaning unable to function without harming self or others, to 100, meaning superior functioning in all areas. The investigators will be assessing this at subject's baseline, after 1 week of treatment (5 treatment sessions, at the end of week 1) and at study completion (approximately 2 weeks after study starts) to see if there is a change over time in this measure.

Countries

United States

Locations and Investigators

  • Edward Hines Jr. VA Hospital, Hines, IL, Hines, United States (Recruiting)
    • William Wolf, PhD
    • Gabriella G Amador
    • Alexandra L Aaronson, MD (Principal Investigator)

Study Officials

  • Alexandra L Aaronson, MD (Principal Investigator) — Edward Hines Jr. VA Hospital, Hines, IL