Using magnetic pulses to treat impulsivity and suicidal thoughts in veterans with mild brain injuries
Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-occurring Mental Health Conditions
This study is testing if a new treatment using magnetic pulses can help veterans with mild brain injuries reduce impulsivity and suicidal thoughts.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Hines, Illinois) |
| Trial ID | NCT05647044 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of intermittent theta burst stimulation (iTBS) in treating impulsivity and suicidal ideation in veterans who have experienced mild traumatic brain injury (mTBI). The approach involves applying high-powered magnetic pulses to the front of the head to activate brain cells and strengthen connections that may help alleviate these symptoms. Participants will be assessed for their impulsivity and suicidal thoughts, and the data collected will inform future larger studies. The study is particularly significant as there are currently no effective treatments for these co-occurring conditions in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 22-65 who have experienced mild traumatic brain injury and exhibit impulsivity and suicidal ideation.
Not a fit: Patients with a history of moderate to severe traumatic brain injury or those with contraindications to iTBS or MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce impulsivity and suicidal thoughts in veterans with mild traumatic brain injuries.
How similar studies have performed: While transcranial magnetic stimulation has shown promise in treating various conditions, this specific application for impulsivity and suicidal ideation in veterans with mTBI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hines, Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Alexandra L Aaronson, MD — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Alexandra L Aaronson, MD
- Email: Alexandra.Aaronson@va.gov
- Phone: (708) 202-8387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.