Actively Recruiting

Phase 1
Age: 22Years - 65Years
All Genders
ID05647044

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

Led by VA Office of Research and Development · Updated on 2026-04-14

55

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a treatment for suicidal thoughts, impulsivity, and difficulties in social and work functions following a mild traumatic brain injury (mTBI) in Veterans. These symptoms are linked, and the study aims to see if intermittent theta burst stimulation (iTBS), a high-powered magnetic pulse applied to the front of the head, can improve these conditions. The goal is to gather early data on the safety and effects of this treatment, which is approved by the FDA but not yet for these specific symptoms or location. The trial compares active iTBS treatment to a placebo (sham) iTBS. The iTBS is delivered using specialized devices that stimulate the brain to promote connections between brain areas involved in impulsivity and suicidal thinking. This randomized, double-blinded study focuses on Veterans aged 22 to 65 with mTBI, impulsivity, and suicidal ideation. Treatment sessions occur over about two weeks. Participants will be assessed before, during, and after treatment using scales measuring social and occupational functioning and suicidal thoughts. Brain imaging will be done to examine changes in brain connectivity related to treatment. The main outcomes include treatment session completion rates and changes in functioning and suicidal ideation. Safety, tolerability, and feasibility of the treatment will also be monitored throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 22 to 65 years
  • Able to read and speak English
  • Meets criteria for mild traumatic brain injury based on the symptom attribution and classification scale
  • Has suicidal ideation rating greater than 1 within the past month
  • Has a history of impulsivity documented or scores above 20 on the negative urgency impulsivity subscale
Not Eligible

You will not qualify if you...

  • Has contraindications to intermittent theta burst stimulation, such as epilepsy
  • Has contraindications to MRI, including claustrophobia or ferromagnetic metal implants
  • Has an active substance use disorder
  • Has a history of moderate to severe traumatic brain injury
  • Has a history of non-traumatic brain injury like stroke, neurosurgery, or hemorrhage
  • Has a history of or current psychosis not caused by an external factor
  • Is pregnant
  • Has an unstable medical condition
  • Had a major surgery within the past 12 weeks
  • Experienced traumatic brain injury within the past year

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Implementation

Duration - Approximately 2 weeks

Participants receive intermittent theta burst stimulation (iTBS) or placebo iTBS to evaluate its effects on impulsivity and suicidal ideation.

Daily visits for iTBS sessions over 2 weeks

Follow-up

Duration - Up to 2 weeks after treatment

Participants are monitored for changes in social and occupational functioning, impulsivity, and suicidal ideation after completing the iTBS sessions.

1 to 2 visits for outcome assessments

Trial Site Locations

Total: 1 location

1

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States, 60141-3030

Actively Recruiting

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Research Team

A

Alexandra L Aaronson, MD

I

Ibuola Kale

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Frontal Pole Neuromodulation for Impulsivity and Suicidality in Veterans With Mild Traumatic Brain Injury and Common Co-Occurring Mental Health Conditions: Protocol for a Pilot Randomized Controlled Trial.

Alyssa Bernanke, Rebecca Hasley, Niki Sabetfakhri...

https://pubmed.ncbi.nlm.nih.gov/39671573