Standard protocol approvals and participants
neuropsychiatric disease, TBI, headaches, Montgomery-Asberg Depression
Data were collected as part of a pilot randomized clinical trial of rTMS for TBI-D32 potential participants were screened for the study. 15 participants (11 males, ages 19–64) were included if they scored at least 10 on the Montgomery-Asberg Depression Rating Scale (MADRS) and had a history of at least one concussive or moderate TBI. One participant in the sham group was lost to follow-up before starting treatment. The remaining 14 participants completed the intent-to-treat endpoint (MADRS after 10 treatments). Two participants (one active, one sham) missed multiple treatments due to headaches, and were thus unable to complete the full treatment course within the pre-specified 5-weeek timeframe; however, both completed a MADRS and MRI for intent-to-treat analysis. One participant in the sham group chose not to complete a post-treatment MRI scan. This analysis was limited to 13 subjects (10 males) who completed both the pre-treatment and post-treatment scan sessions. Of note, the clinical trial was terminated prior to the first interim analysis (planned at n = 20) because the investigators left the institution for unrelated reasons.10 healthy control subjects (3 males, ages 22–35) with no history of neuropsychiatric disease were chosen randomly from the Human Connectome Project (HCP) database