Combined Neuromodulation and Cognitive Training for Post-mTBI Depression (NCT05682677) | Clinical Trial Compass
RecruitingNot Applicable
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
United States72 participantsStarted 2023-09-19
Plain-language summary
The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female
. All racial and ethnic groups
. Ages 18 to 65
. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
. History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry
. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines two approaches — neuromodulation and cognitive training — to treat depression after a mild traumatic brain injury; can you explain what each of those actually involves and how they would be used together in my specific case?
2Since this trial is listed as Phase NA, which often means it's a feasibility or pilot study rather than a later-stage trial, what does that mean for how much is already known about the safety and effectiveness of this combined approach?
3The trial is measuring depression symptoms using the Hamilton Rating Scale — does that mean my progress would mainly be tracked through questionnaires and interviews, and how would that compare to what you'd monitor if I chose a more standard treatment?
4Given that this study is specifically for people with mild traumatic brain injury or concussion alongside depression, how would you assess whether my current diagnosis fits what the trial is actually looking for before we consider enrolling?
5Are there established treatments for post-concussion depression that I should try first, or would discussing this trial make sense at this stage of my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
Exclusion criteria
. History of moderate, severe, or penetrating TBI
. History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
. Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
. Active manic or psychotic illness per MINI
. Current substance use disorder per MINI
. Current active suicidal or homicidal ideation
. Pregnant or intending to become pregnant within the study period; breastfeeding
. Other sensory conditions or illnesses precluding participation in assessments or treatment