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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 29, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT04142320). This is a study registration, not published results. Lead sponsor: Stanford University. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 41 participants (ACTUAL). Conditions: Major Depressive Disorder. Interventions: DEVICE: Neuronavigated rTMS; DEVICE: sham rTMS. Primary outcome measures: Change in Early-local TMS-evoked Potential (EL-TEP) , Baseline: ~1 hour before first intervention; Pre-intervention: ~1-15 min before first TBS; Post-intervention: ~1-15 min after last TBS, ~100 min after first TBS.. Brief summary: Targeted and individualized treatments for mental health disorders are critically needed. Repetitive transcranial magnetic stimulation (rTMS) represents the front-line of new and innovative approaches to normalizing dysfunctional brain networks in those with mental illness. rTMS is FDA-approved for depression and obsessive-compulsive disorder with clinical trials underway for PTSD and addiction, among others. However, remission rates are suboptimal and ideal stimulation parameters are unknown. We recently completed a randomized, double blind clinical trial and a depression severity biomarker that predicts clinical outcome. The overarching goal of this study is to develop the first broadly generalizable platform for real-time biomarker monitoring and personalized rTMS treatment. We plan to recruit patients with medication-resistant depression and in perform a four-phase, cross-over, double-blind, placebo-controlled trial to 1) identify how standard and optimized rTMS patterns engage the depression severity biomarker, and 2) determine the dose-response of these rTMS patterns. Findings from this study will provide the basis for a double-blind, randomized clinical trial comparing rTMS optimized to the individual against standard rTMS.