Neuronavigated aiTBS for TRD

The purpose of this study is to confirm the efficacy of two recently introduced repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation - in treatment-resistant depression (TRD). Using a three-arm design (neuronavigated aiTBS, non-neuronavigated aiTBS, and sham), this randomized controlled trial (RCT) is the first to specifically investigate the incremental benefit of neuronavigation within an accelerated stimulation protocol, as well as the first confirmatory RCT comparing the efficacy of each of these active treatments vs. sham, overcoming previous generalizability issues and being conducted in an independent, multicenter US TRD sample.

NCT Number	NCT07329153
Lead Sponsor	University of Texas Southwestern Medical Center Collaborators: University of California, San Diego, Cornell University
Conditions	Treatment Resistant Depression (TRD)
Enrollment	247 participants
Start Date	2026-07
Primary Completion	2031-06 (estimated)
Study Completion	2031-09 (estimated)
Updated on ClinicalTrials.gov	2026-01-09