RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-20
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05647044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22-65 years of age
  2. * can read and speak English
  3. * meets criteria for mTBI according to the symptom attribution and classification (SACA) scale
  4. * Has a C-SSRS (suicidal ideation rating) of \>1 within the past month
  5. * Has a history of impulsivity documented in the medical chart and/or a score of \>20 on the UPPS-P negative urgency impulsivity subscale
  1. * Has contraindications to iTBS (i.e., epilepsy)
  2. * Has contraindications to MRI (i.e., claustrophobia, ferromagnetic metal implants)
  3. * Has an active substance use disorder per the DSM-V criteria
  4. * Has a history of moderate to severe TBI
  5. * Has a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)
  6. * Has a history of, or current psychosis not due to an external cause
  7. * Is pregnant
  8. * Has an active, unstable medical condition
  9. * Is within 12 weeks of a major surgery or operation
  10. * Is within 1 year of TBI

Contacts and Locations

Study Contact

Alexandra L Aaronson, MD
CONTACT
(708) 202-8387
Alexandra.Aaronson@va.gov
Ibuola Kale
CONTACT
(708) 202-5898
Ibuola.Kale@va.gov

Principal Investigator

Alexandra L Aaronson, MD
PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL

Study Locations (Sites)

Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Alexandra L Aaronson, MD, PRINCIPAL_INVESTIGATOR, Edward Hines Jr. VA Hospital, Hines, IL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury
  • Suicidal Ideation
  • Impulsivity