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

NCT05647044 | Recruiting Phase 1 FDA Device

• 1 other identifier: D4298-W
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Session Completion Rate

  For establish intervention feasibility and tolerability, the study will tract the number of completed iTBS sessions and compute completion percentage rates for each participant.

  Endpoint - after last iTBS session, approximately 2 weeks

• Change in Social and Occupational Functioning Assessment Scale (SOFAS)

  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.

  Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins

Secondary Outcomes (1)

• Change in Columbia Suicide severity rating scale (C-SSRS)

  Rated at baseline, study midpoint (at the end of week 1) and study completion, approximately 2 weeks after study begins.

Study Arms (2)

active iTBS

ACTIVE COMPARATOR

Subjects receiving active iTBS treatment

Device: intermittent theta burst stimulation

placebo iTBS

PLACEBO COMPARATOR

Subjects receiving placebo (sham) iTBS treatment

Device: placebo intermittent theta burst stimulation

Interventions

intermittent theta burst stimulation DEVICE

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.

Also known as: iTBS

active iTBS

placebo intermittent theta burst stimulation DEVICE

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.

Also known as: placebo iTBS

placebo iTBS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

RECRUITING

Related Publications (1)

• Bernanke A, Hasley R, Sabetfakhri N, de Wit H, Smith BM, Wang L, Brenner LA, Hanlon C, Philip NS, Ajilore O, Herrold A, Aaronson A. 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. JMIR Res Protoc. 2024 Dec 13;13:e58206. doi: 10.2196/58206.

  PMID: 39671573 DERIVED

MeSH Terms

Conditions

Brain Concussion; Suicidal Ideation; Impulsive Behavior; Brain Injuries, Traumatic; Brain Injuries; Self-Injurious Behavior; Suicide, Attempted; Suicide; Risk-Taking; Brain Diseases; Craniocerebral Trauma; Mental Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior

Study Officials

• Alexandra L Aaronson, MD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra L Aaronson, MD

CONTACT

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

Ibuola Kale

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a triple blinded study with participants, investigators and outcomes assessors all masked until study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P and Magpro C-B60

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 12, 2022
• Study Start: May 20, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After primary publication of study data
• Access Criteria: The data will be available upon request by researchers and scientists in accordance with federal guidelines and local policy.

Locations

US (1)