Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- iTBS
- sham iTBS
- Personalized, Augmented Cognitive Training (PACT)
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Diego
Lead sponsor
San Diego Veterans Healthcare System
Collaborator
Source ClinicalTrials.gov