NCT07329153

Neuronavigated aiTBS for TRD

Neuronavigated and Non-Neuronavigated Accelerated Intermittent Theta-Burst Stimulation for Treatment-Resistant Depression A Sham-Controlled Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Treatment Resistant Depression (TRD)

Interventions

Type	Name	Description
DEVICE	aiTBS	Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation.

Timeline

• Start date: 2026-07-01
• Primary completion: 2031-06-01
• Completion: 2031-09-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study