Actively Recruiting

Phase 1
Age: 22Years - 65Years
All Genders
NCT05647044

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

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

55

Participants Needed

1

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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...

  • Age between 22 and 65 years
  • Ability to read and speak English
  • Meets criteria for mild traumatic brain injury (mTBI) based on symptom classification
  • Suicidal ideation rating (C-SSRS) greater than 1 within the past month
  • History of impulsivity documented in medical records or a score above 20 on the negative urgency impulsivity scale
Not Eligible

You will not qualify if you...

  • Contraindications to iTBS such as epilepsy
  • Contraindications to MRI such as claustrophobia or metal implants
  • Active substance use disorder according to DSM-V
  • History of moderate to severe traumatic brain injury
  • History of non-traumatic brain injury like stroke, neurosurgery, or hemorrhage
  • History of or current psychosis not caused by external factors
  • Pregnancy
  • Active, unstable medical conditions
  • Within 12 weeks of major surgery or operation
  • Within 1 year of traumatic brain injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

I

Ibuola Kale

CONTACT

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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