rTMS for Military TBI-related Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
About this trial
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
Qualifiers
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 .
Positive Loss of Consciousness of <30 minutes as confirmed by the TBI Screener and/or medical records and/or;
Disqualifiers
History of unprovoked seizures.
History of seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion.
Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).
History of Moderate, Severe, or Penetrating TBI based on TBI Screener and/or medical records.
Trial design
Treatments tested in this trial
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Sham rTMS
Treatment groups
198 Participants
are divided into 3 treatment groupsSponsors and collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov