RecruitingPhase 1NCT05647044

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

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


Sponsor

VA Office of Research and Development

Enrollment

55 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called intermittent theta burst stimulation and a medical device called placebo intermittent theta burst stimulation for people with impulsivity, mild traumatic brain injury, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEintermittent 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.

DEVICEplacebo 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.


Locations(1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

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NCT05647044


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