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Depressive SymptomsADEPTNCT05426967

rTMS for Military TBI-related Depression

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depressive Symptoms and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
Repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
3 sitesUnited States
Study dates
16 Dec 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • Positive Loss of Consciousness of <30 minutes as confirmed by the TBI Screener and/or medical records and/or;
  • Positive Alteration of Consciousness of <24 hours as confirmed by the TBI Screener and/or medical records and/or;
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  • 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.

Who cannot join

  • Elevated risk of seizures at the time of rTMS including any of the following:
  • 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.
  • Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigators, would increase seizure risk.
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  • 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.)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth N Diaz Nelson, MPH contact

832-671-9532

elizabeth.nelson.ctr@usuhs.edu

United States3 sites, 3 recruiting

  • Alexander T. Augusta Military Medical Center

    Fort Belvoir, Virginia, 22060

    Vanessa Donahue, BS

    Zachary J Craig, MD

    Recruiting

  • William Beaumont Army Medical Center

    Fort Bliss, Texas, 79918

    Diana Hernandez, (915) 248-8029, diana.hernandez.ctr@usuhs.edu

    Cuong Phan, APRN, MSN, MSW, AGCNS-BC, (984) 325-9458, cuong.phan.ctr@usuhs.edu

    Recruiting

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

    Rachel Dieterich, Rachel.Dieterich@va.gov

    Maheen M Adamson, PhD

    Recruiting

Other trials in United States

About this study

Official title: ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols

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).

Read the detailed description

In United States Military personnel, rates of depression may increase after mild traumatic brain injury, or concussion. rTMS may hold a therapeutic potential for alleviating symptoms of depression after concussion. This study is a randomized, double-blind, Bayesian adaptive trial aimed at determining the safety, efficacy, and tolerability of individualized connectome targeted (ICT)-accelerated intermittent Theta Burst Stimulation (aiTBS) and scalp-targeted aiTBS for the treatment of depressive symptoms in a properly powered sample of current and former US military service members with a history of concussion.

Being tested
Repetitive Transcranial Magnetic Stimulation (rTMS), Sham rTMS
Keywords
Transcranial Magnetic Stimulation (TMS), Depressive Symptoms, Concussion, Mild Traumatic Brain Injury (TBI), Functional Magnetic Resonance Imaging (fMRI)
Medical subject headings
Depression, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic Stimulation (rTMS)Device

    Active rTMS

  • Sham rTMSDevice

    Sham comparator to active rTMS

Study groups in NCT05426967
Study groupRoleWhat they receive
Arm 1ExperimentalActive rTMS/Individualized Connectome Targeting (ICT)
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm 2ExperimentalActive rTMS/resting state functional MRI (rsfMRI)-based targeting
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm 3Sham comparatorSham rTMS
Receives: Device: Sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

    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.

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  2. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup

    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.

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  3. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up

    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.

    Measured: Baseline to 6 months

  4. Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

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

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  5. Comparison of Duration of Remission of Depressive Symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

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

    Measured: Follow-up Period, from 1-6 months after the final rTMS session

  6. Comparison of Frequency of Adverse Events

    Comparison of AEs between groups

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

Secondary outcomes (11)

  1. Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to post-intervention

    Change in Inventory of Depressive Symptomatology-Self Report scores between groups. The Report is a 30-item self-report depressive symptom severity rating scale, with each question on a scale of 0 to 4; and a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression.

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  2. Comparison of Change in Symptoms of Major Depressive Disorder Scale (SMDDS) Scores from Baseline to Post-intervention

    Change in Symptoms of Major Depressive Disorder Scale scores between groups. The Scale is a 16-question scale, with each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"); the total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  3. Comparison of Change in Inventory of Depressive Symptomatology-Self Report (IDS-SR) Scores from Baseline to 6-month follow-up

    Change in Inventory of Depressive Symptomatology-Self Report scores between groups. The Report is a 30-item self-report depressive symptom severity rating scale, with each question on a scale of 0 to 4; and a score range between 0 to 84, with a higher score reflecting higher symptom severity in depression

    Measured: Baseline to 6-month follow-up

  4. Comparison of Change in Symptoms of Major Depressive Disorder Scale (SMDDS) Scores from Baseline to 6-month follow-up

    Change in Symptoms of Major Depressive Disorder Scale scores between groups. The Scale is a 16-question scale, with each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"); the total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.

    Measured: Baseline to 6-month follow-up

  5. Comparison of Change in TBI Quality of Life Scale (TBI-QOL) Subtest Scores from Baseline to Post-intervention

    Change in subtest scores between groups Anxiety ranges Raw Score (RS) 10-50, T-score 36.0-85.1; higher = worse Communication ranges RS 9-45, T-score 12.8-67.2; higher = better Depression ranges RS 10-50, T-score 38.3-82.6; higher = worse Emotional \& Behavioral Dyscontrol ranges RS 10-50, T-score 33.1-84.6; higher = worse Executive Function range RS 10-50, T-score 12.3-58.0; higher = better Fatigue ranges RS 10-50, T-score 32.7-80.7; higher = worse General Concerns ranges RS 10-50, T-score 17.3-59.6; higher = better Grief - Loss ranges RS 9-45, T-score 32.9-75.0; higher = worse Headache ranges RS 10-50, T-score 38.9-72.6; higher = worse Independence ranges RS 8-40, T-score 21.2-66.2; higher = better Pain Interference ranges RS 10-50, T-score 40.4-78.8; higher = worse Resilience ranges RS 10-50, T-score 15.3-69.2; higher = better Self-Esteem ranges RS 10-50, T-score 20.0-64.9; higher = better Cognitive Function ranges RS 8-40, T-score 22.5-67.0; higher = better

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  6. Comparison of Change in TBI Quality of Life Scale (TBI-QOL) Subtest Scores from Baseline to 6-month follow-up

    Change in subtest scores between groups Anxiety ranges Raw Score (RS) 10-50, T-score 36.0-85.1; higher = worse Communication ranges RS 9-45, T-score 12.8-67.2; higher = better Depression ranges RS 10-50, T-score 38.3-82.6; higher = worse Emotional \& Behavioral Dyscontrol ranges RS 10-50, T-score 33.1-84.6; higher = worse Executive Function range RS 10-50, T-score 12.3-58.0; higher = better Fatigue ranges RS 10-50, T-score 32.7-80.7; higher = worse General Concerns ranges RS 10-50, T-score 17.3-59.6; higher = better Grief - Loss ranges RS 9-45, T-score 32.9-75.0; higher = worse Headache ranges RS 10-50, T-score 38.9-72.6; higher = worse Independence ranges RS 8-40, T-score 21.2-66.2; higher = better Pain Interference ranges RS 10-50, T-score 40.4-78.8; higher = worse Resilience ranges RS 10-50, T-score 15.3-69.2; higher = better Self-Esteem ranges RS 10-50, T-score 20.0-64.9; higher = better Cognitive Function ranges RS 8-40, T-score 22.5-67.0; higher = better

    Measured: Baseline to 6-month follow-up

  7. Comparison of Change in PTSD Checklist for DSM-5 (PCL-5) Scores from Baseline to Post-intervention

    Change in PTSD Checklist for DSM-5 scores between groups. The Checklist is a self-reported measure of PTSD symptom severity, with a score range of 0-84 in which a higher score represents greater severity.

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  8. Comparison of Change in PTSD Checklist for DSM-5 (PCL-5) Scores from Baseline to 6-month Follow-up

    Change in PTSD Checklist for DSM-5 scores between groups. The Checklist is a self-reported measure of PTSD symptom severity, with a score range of 0-84 in which a higher score represents greater severity.

    Measured: Baseline to 6-month follow-up

  9. Compliance Assessment

    Proportion of participants who achieve at least 80% compliance, defined as having completed ≥16 rTMS sessions

    Measured: Post-intervention, within 10 working days of the final rTMS session

  10. Comparison of Change in rsfMRI Connectivity from Baseline to Post-intervention

    Compare change in rsfMRI connectivity, focusing on brain networks relevant to mood regulation between groups

    Measured: Baseline to post-intervention, within 10 working days of the final rTMS session

  11. Comparison of Change in rsfMRI Connectivity from Baseline to 6-month Follow-up

    Compare change in rsfMRI connectivity, focusing on brain networks relevant to mood regulation between groups

    Measured: Baseline to 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start16 Dec 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Bayesian-adaptive trial design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426967
Sponsor's protocol ID
USUHS-2020-050
Acronym
ADEPT
Status last verified
Apr 2026
First submitted
7 Mar 2022
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository

Publications

  • Oberman LM, Penafiel AI, Dieterich R, Phan CT, Chou YY, Pham DL, Adamson MM, Hines CE, Rezaee Z, Deng ZD, Pal H, Lisanby SH, Brody DL. Adaptive trial for the treatment of depressive symptoms associated with concussion using accelerated intermittent theta burst stimulation (ADEPT): rationale, design and methods. Front Neurol. 2025 Jun 13;16:1605157. doi: 10.3389/fneur.2025.1605157. eCollection 2025.

    PubMed 40584527

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Depressive Symptoms and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth N Diaz Nelson, MPH (832-671-9532, elizabeth.nelson.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores (time frame: Baseline to post-intervention, within 10 working days of the final rTMS session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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