Neuronavigated aiTBS for TRD

Part of paid clinical trials in San Diego, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07329153
Status
Not Yet Recruiting

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Conditions

  • Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • aiTBS — DEVICE
    Repetitive transcranial magnetic stimulation (rTMS) interventions - accelerated intermittent theta-burst stimulation (aiTBS) and individualized neuronavigation.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
247 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neuronavigated aiTBS
    TBS device placement during treatment determined by MRI imaging
  • Active Comparator: Non-Neuronavigated aiTBS
    Conventional device placement during treatment
  • Sham Comparator: Sham aiTBS
    identical procedures as the other 2 groups but without turning on the device

Primary Outcome Measure

HDRS-17 - Depression severity assessment [ Time Frame: From Baseline visit until week 5 visit ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California at San Diego (UCSD)San DiegoCalifornia92127
UCSD Interventional Psychiatry
[email protected]
858-207-0938
Greg Appelbaum, PhD (PRINCIPAL_INVESTIGATOR)
Cornell UniversityNew YorkNew York10065
Interventional Psychiatry Program Weill Cornell Medicine
[email protected]
646-962-2900
Conor Liston, MD PhD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Clinical Research Coordinator
[email protected]
214-645-2991
Andre Russowsky Brunoni, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California at San Diego (UCSD)· San Diego, CACornell University· New York, NYUniversity of Texas Southwestern Medical Center· Dallas, TX

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