rTMS for Military TBI-related Depression
ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 55 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests two ways to use rTMS, a treatment that uses magnetic pulses to stimulate the brain, for depression. It is for U.S. military members and veterans who have had a concussion, or mild brain injury. Researchers will check how well the treatments work, how safe they are, and how well people tolerate them.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–55 years old.
- You are a current or former U.S. military member who can get care at a military or VA medical center.
- You can understand and sign an English consent form.
- You had a concussion more than 6 months but less than 26 years ago. It involved passing out for under 30 minutes, changed awareness for under 24 hours, or memory loss lasting up to 1 day. Your own report is allowed; scans and medical records are not required.
- Your score is above 13 on the MADRS depression rating scale, showing at least mild to moderate symptoms.
- Your mental health medicines have stayed the same for 6 weeks, and your behavioral therapy has stayed the same for 12 weeks.
- If you are female and could become pregnant, you agree to use effective birth control during the study.
- You are under the care of a primary care or mental health provider.
Who can't join
- You have a higher seizure risk. This includes certain personal or family seizure histories, a past moderate, severe, or penetrating brain injury, or brain problems, medicines, or substances that raise seizure risk.
- You cannot safely have the required MRI brain scan or TMS, or cannot have the MRI while awake without calming medicine. Certain implants, brain problems that distort scan results, or a severe fear of tight spaces may rule you out.
- You have a history of severe or recently uncontrolled heart disease, a heart pacemaker, or lines inside your heart. You have a quickly worsening illness, such as late-stage cancer, a disease that damages the nervous system, or major organ failure.
- You have a history of bipolar disorder or schizophrenia-related disorders; current psychosis, meaning trouble knowing what is real; mood problems caused by substances; depression caused by a medical illness other than brain injury; or severe or uncontrolled substance use.
- You have ever received open-label TMS, meaning you knew you were getting TMS. You are receiving another brain stimulation treatment now or received one within the past 12 weeks.
- You attempted suicide within the past 6 months.
- Your right arm is missing, or another condition prevents the team from setting the stimulation level. You cannot finish the study, are a prisoner, or have legal limits on your movement or participation.
- The study team finds another concern about safety, participation, or reliable study results. This may include trouble communicating consistently or keeping your medicines or therapy steady.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.)
Study sites (3)
CA
- VA Palo Alto Health Care System · Palo Alto, CA 94304Rachel Dieterich · Study contact · Rachel.Dieterich@va.govMaheen M Adamson, PhD · Principal investigatorMore trials in Palo Alto
TX
- William Beaumont Army Medical Center · Fort Bliss, TX 79918Diana Hernandez · Study contact · (915) 248-8029 · diana.hernandez.ctr@usuhs.eduCuong Phan, APRN, MSN, MSW, AGCNS-BC · Study contact · (984) 325-9458 · cuong.phan.ctr@usuhs.eduJesse Wolfe, MD · Principal investigatorMore trials in Fort Bliss
VA
- Alexander T. Augusta Military Medical Center · Fort Belvoir, VA 22060Vanessa Donahue, BS · Study contactZachary J Craig, MD · Principal investigatorMore trials in Fort Belvoir