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

Part of paid clinical trials in Hines, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT05647044
Phase
PHASE1
Status
Recruiting
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Conditions

  • Impulsivity
  • Mild Traumatic Brain Injury
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 20, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: active iTBS
    Subjects receiving active iTBS treatment
  • Placebo Comparator: placebo iTBS
    Subjects receiving placebo (sham) iTBS treatment

Primary Outcome Measure

Session Completion Rate [ Time Frame: Endpoint - after last iTBS session, approximately 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
William Wolf, PhD
[email protected]
708-202-5689
Gabriella G Amador
[email protected]
Alexandra L Aaronson, MD (PRINCIPAL_INVESTIGATOR)

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Edward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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