Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female 2. All racial and ethnic groups 3. Ages 18 to 65 4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health 5. 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 6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI 7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms 8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period 9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) 10. No contraindications to MRI (passes MRI safety screening questionnaire) 11. Able to commit to the treatment schedule 12. Able to complete assessment procedures in English 13. Intact decision-making capacity and ability to provide voluntary informed