Actively Recruiting
rTMS for Military TBI-related Depression
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2026-04-29
198
Participants Needed
3
Research Sites
106 weeks
Total Duration
On this page
Sponsors
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
U
Uniformed Services University of the Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
rTMS for Military TBI-related Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years at the time of consent
- Current or former U.S. military service member eligible for care at a Military Treatment Facility or Veterans Administration Medical Center
- Able to provide written informed consent in English
- Self-reported or medically diagnosed concussion (mild TBI) more than 6 months and less than 26 years prior to consent, confirmed by loss or alteration of consciousness or post-traumatic amnesia
- Baseline Montgomery-Asberg Depression Rating Scale (MADRS) score greater than 13 indicating mild to moderate depressive symptoms
- Maintained steady psychotropic medication regimen for six weeks prior to enrollment
- Maintained steady behavioral therapy regimen for twelve weeks prior to enrollment
- Female participants of child-bearing potential must agree to use effective birth control during the study
- Under care of a primary care and/or behavioral health provider
You will not qualify if you...
- Elevated risk of seizures including history of unprovoked seizures or seizures within 24 hours of concussion
- Family history of two or more unprovoked seizures in first degree relatives
- History of moderate, severe, or penetrating TBI
- Intracranial lesions increasing seizure risk or compromising MRI data
- Contraindications to awake 3T MRI without contrast
- Severe claustrophobia interfering with MRI
- Severe or recent uncontrolled heart disease
- Presence of cardiac pacemaker, intracardiac lines, or certain implants/prostheses unsafe with MRI or TMS
- Rapidly progressive illnesses such as late-stage cancer or major organ failure
- History of bipolar disorder or schizophrenia spectrum disorders
- Current substance-induced mood disorder, active psychosis, or depression due to general medical illness other than TBI
- Severe or uncontrolled substance use
- Prior open-label TMS or recent neurostimulatory treatments within 12 weeks
- Suicide attempt within six months prior to enrollment
- Right upper extremity amputation or conditions precluding motor threshold calibration
- Unable to complete study timeline (e.g., planned hospitalization)
- Prisoner or legally restricted freedom of movement
- Any other investigator concerns affecting safety, participation, or data validity
AI-Screening
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Trial Site Locations
Total: 3 locations
1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Actively Recruiting
2
William Beaumont Army Medical Center
Fort Bliss, Texas, United States, 79918
Actively Recruiting
3
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, United States, 22060
Actively Recruiting
Research Team
E
Elizabeth N Diaz Nelson, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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