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rTMS for Depression in Military Members with Concussion

This study is looking at how well repetitive transcranial magnetic stimulation (rTMS) works to help military service members and veterans who have depression after a concussion or mild traumatic brain injury (TBI). We are testing two types of rTMS: Active rTMS and Sham rTMS (a placebo version). To join, you must be a current or former U.S. military service member between 18 and 55 years old, and able to give consent in English. The study will measure success by looking at changes in your depression symptoms using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS). The current recruitment status is unclear.

Study design
This is a randomized, double-blind study aiming to enroll 198 participants. It compares two types of rTMS: Active rTMS and Sham rTMS.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be checked again at 6 months after the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05426967

rTMS for Military TBI-related Depression

Recruiting
NAAges 18–55InterventionalTreatment
Henry M. Jackson Foundation for the Advancement of Military Medicine
~198 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Repetitive Transcranial Magnetic Stimulation (rTMS)Sham rTMS

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores
Measured over Baseline to post-intervention, within 10 working days of the final rTMS session
+5 more outcomes measured

Conditions

Depressive Symptoms
Mild Traumatic Brain Injury
Concussion

Explore related trials

ConcussionDepression

Where it's being run

3 sites across 3 states
California1
Texas1
Virginia1

Study leadership

  • David L Brody, MD, PhD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

Who to contact

Elizabeth N Diaz Nelson, MPH
[email protected]
832-671-9532
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

Elevated risk of seizures at the time of rTMS including any of the following:
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.)

What this trial measures

  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) ScoresBaseline to post-intervention, within 10 working days of the final rTMS session

    Change in Montgomery-Asberg Depression Rating Scale scores from baseline to post-intervention between groups. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a SubgroupBaseline to post-intervention, within 10 working days of the final rTMS session

    Change in Montgomery-Asberg Depression Rating Scale scores between groups from Baseline to post-intervention in participants who complete ≥80% of rTMS sessions. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-upBaseline to 6 months

    Change in Montgomery-Asberg Depression Rating Scale scores from baseline to 6-month follow-up between groups. The Scale is designed to measure depression severity and consists of 10 items, each of which is scored on a Likert scale from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  • Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) ScoresBaseline to post-intervention, within 10 working days of the final rTMS session

    Comparison of proportion of participants in each condition achieving treatment response ≥50% improvement in MADRS) or remission (MADRS ≤10)

  • Comparison of Duration of Remission of Depressive Symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) ScoresFollow-up Period, from 1-6 months after the final rTMS session

    Comparison of duration of remission of depressive symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) Scores between groups assessed monthly during follow-up

  • Comparison of Frequency of Adverse EventsBaseline to post-intervention, within 10 working days of the final rTMS session

    Comparison of AEs between groups