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NCT04142320
Closed-loop Optimized rTMS for Depression
Phase 1 trial testing closed-loop rTMS in Major Depressive Disorder in 44 participants. Completed in 10 July 2025.
10 July 2025
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 44 |
| Start date | 1 June 2021 |
| Primary completion | 10 July 2025 |
| Estimated completion | 10 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- closed-loop rTMS
- open-loop rTMS
- sham rTMS
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Stanford University
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Closed-loop neurostimulation for the treatment of psychiatric disorders.
Sellers KK, Cohen JL, Khambhati AN, Fan JM, et al · · 2024 · cited 26× · PMID 37369777 · DOI 10.1038/s41386-023-01631-2
Verify or expand the search:
- PubMed search for NCT04142320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other Stanford University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04142320 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04142320.
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