Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Depression, Mild Traumatic Brain Injury, Concussion, Brain
About this trial
This is an interventional treatment trial for Depression focused on measuring brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation
Eligibility Criteria
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 Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) No contraindications to MRI (passes MRI safety screening questionnaire) Able to commit to the treatment schedule Able to complete assessment procedures in English Intact decision-making capacity and ability to provide voluntary informed consent 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 Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy Taking medication that lowers seizure threshold Previous failed treatment with rTMS, iTBS, or ECT Completed >4 sessions of cognitive rehabilitation within the last 3 years
Sites / Locations
- UCSDRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
PACT+iTBS
PACT+sham iTBS
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)