fMRI-neuronavigated rTMS Treatment for Symptoms of Depression Associated With Concussive TBI in the Military Population

NCT03523507 NA TERMINATED

This study aims to investigate the efficacy and tolerability of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in the treatment of depressive symptoms in service members with a history of concussive traumatic brain injury (TBI). Up to ninety participants will be randomized to active or sham treatment. Participants randomized into the active group will receive 20 sessions of left-sided dorsolateral prefrontal cortex (DLFPC) high-frequency rTMS, followed by right-sided DLFPC low-frequency rTMS. The DLPFC treatment area will be identified by using individual subject-level resting state network estimation (Hacker et al., 2013). Participants randomized into the sham treatment group will receive 20 sham treatments designed to have similar sound and tactile sensation, without producing active treatment. Participants will also be asked to complete regular follow-up evaluations for up to a total of six follow-up sessions. Those who do not respond to the treatment will have the option to receive active treatment through this study regardless of group assignment to active or sham.

Details

Lead sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine
Phase	NA
Status	TERMINATED
Enrolment	10
Start date	Mon Jul 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Oct 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Traumatic Brain Injury
• Concussion, Mild
• Depressive Symptoms

Interventions

• Active: rTMS
• Sham: rTMS

Countries

United States