Trials
Search / Trial NCT05647044

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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 2, 2022

Trial Information

Current as of January 22, 2025

Recruiting

Keywords

Brain Concussion Brain Injuries, Traumatic Brain Injuries Self Injurious Behavior Suicide, Attempted Suicide Impulsive Behavior Risk Taking Brain Diseases Craniocerebral Trauma Social Problems Mental Disorders

ClinConnect Summary

This clinical trial is exploring a new treatment for veterans experiencing problems like suicidal thoughts, impulsivity, and difficulties functioning socially or at work after having a mild traumatic brain injury (mTBI). Researchers are using a method called intermittent theta burst stimulation (iTBS), which involves sending high-powered magnetic pulses to the front of the head. This treatment aims to activate certain brain cells and strengthen connections in the brain. The goal is to see if iTBS can help improve these symptoms and gather information for future studies.

To be part of this trial, participants need to be between 22 and 65 years old, able to read and speak English, and have been diagnosed with mTBI. They should also have experienced suicidal thoughts in the past month and a history of impulsivity. However, not everyone will be eligible; those with conditions like epilepsy, active substance use disorders, or significant past brain injuries will be excluded. Those who join can expect to receive iTBS treatment while being monitored for safety and effectiveness. This research is an important step towards finding better treatments for those affected by mTBI.

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Alexandra L Aaronson, MD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Hines, Illinois, United States

Hines, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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