NCT05647044 Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
| NCT ID | NCT05647044 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | VA Office of Research and Development |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2024-05-20 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alexandra L Aaronson, MD
PRINCIPAL INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL
Frequently Asked Questions
Who can join the NCT05647044 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05647044 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05647044 currently recruiting?
Yes, NCT05647044 is actively recruiting participants. Contact the research team at Alexandra.Aaronson@va.gov for enrollment information.
Where is the NCT05647044 trial being conducted?
This trial is being conducted at Hines, United States.
Who is sponsoring the NCT05647044 clinical trial?
NCT05647044 is sponsored by VA Office of Research and Development. The principal investigator is Alexandra L Aaronson, MD at Edward Hines Jr. VA Hospital, Hines, IL. The trial plans to enroll 55 participants.