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

This study is looking for Veterans aged 22-65 who have had a mild traumatic brain injury (mTBI) and are experiencing suicidal thoughts and impulsivity. The researchers want to see if a treatment called intermittent theta burst stimulation (iTBS) can help. iTBS uses a magnetic pulse applied to the head to activate brain cells and strengthen connections. You would receive either active iTBS or a placebo (inactive) iTBS. The study aims to gather early information on how safe and effective iTBS is for improving impulsivity, suicidal thoughts, and daily functioning after an mTBI. Success would be measured by how many sessions you complete and improvements in your social and work functioning over about two weeks.

Study design
This interventional study plans to enroll 55 participants. It compares active intermittent theta burst stimulation (iTBS) to a placebo iTBS.
What's involved
You would participate in iTBS sessions over approximately two weeks. Your social and occupational functioning would be rated at the beginning, middle, and end of the study.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at the end of the iTBS sessions, approximately two weeks after the study begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05647044

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

Recruiting
PHASE1Ages 22–65InterventionalTreatment
VA Office of Research and Development
~55 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:intermittent theta burst stimulationplacebo intermittent theta burst stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Session Completion Rate
Measured over Endpoint - after last iTBS session, approximately 2 weeks
+1 more outcome measured

Conditions

Mild Traumatic Brain Injury
Suicidal Ideation
Impulsivity

Explore related trials

ConcussionImpulsive BehaviorSuicidal Ideation

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

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

Who to contact

Alexandra L Aaronson, MD
[email protected]
(708) 202-8387
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Session Completion RateEndpoint - 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.