Neuronavigated aiTBS for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with treatment-resistant depression, having tried maximum dose antidepressants for 6 weeks or completed at least 12 sessions of psychotherapy. Participants must have moderate to severe depression as measured by the MADRS score and be stable on their current medication for at least six weeks before starting the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neuronavigated aiTBS, non-neuronavigated aiTBS, or sham aiTBS for treatment-resistant depression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- aiTBS
Trial Overview
The study tests neuronavigated accelerated intermittent theta-burst stimulation (aiTBS) against non-neuronavigated aiTBS and a sham procedure in treating major depressive disorder. It's a randomized controlled trial conducted across multiple centers to assess if neuronavigation improves outcomes in an accelerated treatment protocol.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
TBS device placement during treatment determined by MRI imaging
Conventional device placement during treatment
identical procedures as the other 2 groups but without turning on the device
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
University of California, San Diego
Collaborator
Cornell University
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.