Study of Two rTMS Treatments for Depression in U.S. Military Members and Veterans With Concussion History

What this Trial Is About

This research aims to evaluate the safety, effectiveness, and tolerability of two repetitive transcranial magnetic stimulation rTMS protocols targeting the dorsolateral prefrontal cortex to reduce depression symptoms in U.S. military members and veterans with a history of concussion or mild traumatic brain injury. The study uses a randomized, double-blind, Bayesian adaptive design to compare individualized connectome targeted accelerated intermittent Theta Burst Stimulation and scalp-targeted stimulation in this specific population. Participants are assigned randomly to one of three groups active rTMS with individualized connectome targeting, active rTMS with resting state functional MRI-based targeting, or a sham placebo rTMS group. These treatments are delivered as device-based brain stimulation therapies designed to assess their impact on depressive symptoms. The study includes an initial treatment phase followed by post-intervention assessments and a 6-month follow-up period. During the study, participants will undergo evaluations using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms from baseline through post-intervention and at 6 months. Additional assessments include self-reported depression scales, quality of life related to brain injury, PTSD symptoms, and brain connectivity via MRI scans. Researchers will monitor treatment compliance, adverse events, and overall safety throughout the trial, which lasts up to 6 months after final treatment.

rTMS for Military TBI-related Depression