NCT04142320CompletedPhase 1
Closed-loop Optimized rTMS for Depression
Randomized, Cross-over, Placebo-controlled Trial to Determine Target Engagement and Dose Response of Optimized Closed-loop rTMS for Medication-resistant Depression
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 17 Oct 2019
- Start date
- 1 Jun 2021
- Primary completion date
- 10 Jul 2025
- Lead sponsor
- Stanford University
- Diseases
- Depression
- NCT number
- NCT04142320
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 41
- From 1 Jun 2021 to the primary completion date, 10 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A prior history of ECT or rTMS failure
- Currently taking medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
Other illness
- Any unstable medical condition
- History of head trauma with loss of consciousness
- History of seizures
- Neurological or uncontrolled medical disease
- Diagnosis of psychotic or bipolar disorder
Other
- Those with a contraindication for MRIs (e.g. implanted metal)
- Active substance abuse
- Currently pregnant or breastfeeding
Who the study is looking for
- Men and women, ages 18 to 65
- Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- Right-handed
- No current or history of neurological disorders
- No seizure disorder or risk of seizures
- No use of PRN medication within 48 hours of the scheduled study appointment
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.