Using rTMS to treat depression in military personnel with mild TBI
Official title: ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols
Run by Henry M. Jackson Foundation for the Advancement of Military Medicine · NCT05426967 · Data updated 2026-11-12
This study is testing two different types of brain stimulation to see if they can help military personnel and veterans with mild brain injuries feel less depressed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Status | Recruiting |
| Started | December 16, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT05426967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include U.S. military service members or veterans aged 18-55 with a documented history of concussion occurring more than 6 months but less than 26 years prior to consent.
✕Probably not a fit
Patients outside the age range of 18-55 or those without a history of concussion may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the efficacy, safety, and tolerability of two repetitive transcranial magnetic stimulation (rTMS) protocols aimed at alleviating depressive symptoms in U.S. military service members and veterans with a history of concussion or mild traumatic brain injury (TBI). It employs a randomized, double-blind, Bayesian adaptive design to compare individualized connectome targeted (ICT)-accelerated intermittent Theta Burst Stimulation (aiTBS) and scalp-targeted aiTBS. The trial focuses on a properly powered sample of current and former military personnel to assess the therapeutic potential of rTMS for treating depression following concussion.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for military personnel suffering from depression related to mild TBI.
How similar studies have gone: Other studies have shown promise in using rTMS for treating depression, suggesting potential success for this approach in military populations.
Who can join: the full rules
Show full inclusion / exclusion 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 the time of screening indicating at least mild-moderate depressive symptoms.
* Maintained a steady psychotropic medication regimen for six weeks and a steady behavioral therapy regimen for twelve weeks prior to enrollment in the study.
* Female participants with child-bearing potential must agree to use an effective method of birth control during the course of the study.
* Under the care of a primary care and/or behavioral health provider.
Exclusion Criteria:
* Elevated risk of seizures at the time of rTMS including any of the following:
1. History of unprovoked seizures.
2. 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.
3. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child).
4. History of Moderate, Severe, or Penetrating TBI based on TBI Screener and/or medical records.
5. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.
6. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold.
* Contraindications to awake 3T MRI without contrast at the time of the Baseline MRI according to site radiology department criteria.
* Severe claustrophobia interfering with medication/sedation-free 3T closed-bore MRI.
* Intracranial lesion that would produce an artifact that would compromise the integrity of rsfMRI data.
* History of severe or recent uncontrolled heart disease.
* Presence of a cardiac pacemaker or intracardiac lines.
* Any implant, prosthesis or other permanent alteration of the body (such as implanted neurostimulators and medication pumps) that, in the opinion of the investigator, would be unsafe with MRI or TMS or that would produce an artifact that would compromise the integrity of data.
* Presence of rapidly progressive illnesses such as late-stage cancer, neurodegenerative conditions, major organ failure, etc.
* History of Bipolar Disorder or Schizophrenia Spectrum Disorders.
* Current evidence of substance-induced mood disorder, active psychosis, or depression secondary to general medical illness other than TBI.
* Severe or uncontrolled substance use.
* Concomitant or lifetime history of receiving open-label TMS, due to issues preserving blinding.
* Concomitant or recent history (within 12 weeks prior to enrollment) of receiving other neurostimulatory treatment, including but not limited to transcranial direct current (tDCS), transcranial alternating current (tACS), alpha stim, or electroconvulsive therapy.
* Suicide attempt within six months prior to enrollment.
* Right upper extremity amputation or other condition precluding left motor threshold calibration.
* Unable to complete timeline of study (e.g., planned hospitalization partway through the study period.)
* Prisoner, or other legally restricted freedom of movement and participation.
* Any other considerations that, in the opinion of the investigators, may adversely affect participant safety, participation, or the scientific validity of the data being collected (e.g., erratic or unreliable responses, inconsistent communication, inability to remain on a steady neurotropic medication and/or behavioral therapy regimen over the course of the Randomization phase of the study.)
Where it's running
-
VA Palo Alto Health Care System
Palo Alto, California, United States Recruiting -
William Beaumont Army Medical Center
Fort Bliss, Texas, United States Recruiting -
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, United States Recruiting
Study contacts
- Principal investigator: David L Brody, MD, PhD — Uniformed Services University of the Health Sciences
- Study coordinator: Elizabeth N Diaz Nelson, MPH
- Email: elizabeth.nelson.ctr@usuhs.edu
- Phone: 832-671-9532
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CORE: Cognitive Optimization Through Rehabilitation and Education for persistent concussion symptoms
This program tests whether cognitive training plus brain-health education can help Veterans and other adults who still have thinking, memory, or attention problems months after a concussion.
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BCAAs in Concussion: a higher-dose test in teens and young adults
This trial will test whether high-dose branched-chain amino acids help teens and young adults recover from concussion compared with a placebo.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.