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RecruitingNCT05426967

rTMS for Military TBI-related Depression

◆ AI Clinical Summary

This study tests whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, can reduce depression symptoms in military service members and veterans with traumatic brain injury (TBI). rTMS uses magnetic pulses to stimulate specific areas of the brain. The study will evaluate how well two different rTMS treatment approaches work and how safe and well-tolerated they are.

Key Objective:This trial is testing whether rTMS can effectively reduce depression symptoms in military personnel with TBI-related depression, potentially offering a non-medication treatment option.

Who to Consider:U.S. military service members and veterans with a history of traumatic brain injury who are currently experiencing depressive symptoms should consider enrolling in this study.

Trial Parameters

ConditionDepressive Symptoms
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment198
SexALL
Min Age18 Years
Max Age55 Years
Start Date2024-12-16
Completion2026-09-30
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS)Sham rTMS

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Brief Summary

The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).

Eligibility Criteria

Inclusion Criteria: * Age 18-55 at the time of consent. Older individuals will not be enrolled in this initial trial for reasons of safety and expected reduced efficacy. * Current or former US military service member eligible for care at a Military Treatment Facility (MTF) or Veterans Administration Medical Center (VAMC.) * Able to provide written, informed consent in English . * Self-reported or medically diagnosed history of concussion (synonymous with "mild TBI.") \>6 months, but \<26 years prior to consent, defined based on the DoD/VA definition: 1. Positive Loss of Consciousness of \<30 minutes as confirmed by the TBI Screener and/or medical records and/or; 2. Positive Alteration of Consciousness of \<24 hours as confirmed by the TBI Screener and/or medical records and/or; 3. Positive Post-traumatic Amnesia of 0 to 1 day as confirmed by the TBI Screener and/or medical records. * Note: Neuroimaging data or documentation from medical records is not required. * Baseline MADRS \>13 at

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