Recruiting

Phase 1

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

Sponsor:

VA Office of Research and Development

Code:

NCT05647044

Conditions

Mild Traumatic Brain Injury

Suicidal Ideation

Impulsivity

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

intermittent theta burst stimulation

placebo intermittent theta burst stimulation

Study Details

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.

Conditions

Mild Traumatic Brain Injury

Suicidal Ideation

Impulsivity

Study ID

NCT05647044

Start date

May 20, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: active iTBS

Subjects receiving active iTBS treatment

placebo comparator: placebo iTBS

Subjects receiving placebo (sham) iTBS treatment

Interventions

intermittent theta burst stimulation

intermittent theta burst stimulation (iTBS) will be delivered with the Magventure MagProX100 with MagOption stimulation and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo. The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.

placebo intermittent theta burst stimulation

Primary outcome measure

Session Completion Rate [ Time Frame: Endpoint - after last iTBS session, approximately 2 weeks ]
Change in Social and Occupational Functioning Assessment Scale (SOFAS) [ Time Frame: Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins ]

Central Contacts and Locations

Central contacts

Alexandra L Aaronson, MD

(708) 202-8387 Alexandra.Aaronson@va.gov

Ibuola Kale

(708) 202-5898 Ibuola.Kale@va.gov

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

William Wolf, PhD

708-202-5689 William.Wolf@va.gov

Gabriella G Amador

Gabriella.Amador@va.gov

Principal Investigator:

Alexandra L Aaronson, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

brain concussion
brain injuries, traumatic
brain injuries
self-injurious behavior
suicide, attempted
suicide
impulsive behavior
risk-taking
brain diseases
craniocerebral trauma
social problems
mental disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-14.