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NCT05647044
Frontal iTBS for Impulsivity and Suicidal Ideation in Veterans With Mild Traumatic Brain Injury
Conditions: Mild Traumatic Brain Injury, Suicidal Ideation, Impulsivity
Sex: All
Ages: 22 Years – 65 Years
Phase: PHASE1
Enrollment: 55
Sponsor: VA Office of Research and Development
Location: United States
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 Criteria
Inclusion Criteria:22-65 years of agecan read and speak Englishmeets criteria for mTBI according to the symptom attribution and classification (SACA) scaleHas a C-SSRS (suicidal ideation rating) of >1 within the past monthHas a history of impulsivity documented in the medical chart and/or a score of >20 on the UPPS-P negative urgency impulsivity subscaleExclusion 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 criteriaHas a history of moderate to severe TBIHas a history of non-traumatic neuroinjury (i.e., stroke, neurosurgery, hemorrhage)Has a history of, or current psychosis not due to an external causeIs pregnantHas an active, unstable medical conditionIs within 12 weeks of a major surgery or operationIs within 1 year of TBI
Source: ClinicalTrials.gov (NCT05647044). StuddyBuddy aggregates publicly available trial information.