Closed-loop Optimized rTMS for Depression
Completed · Phase 1 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT04142320
- Run by
- Stanford University
- People needed
- 44
- Starts
- 2021-06-01
- Expected to finish
- 2025-07-10
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women, ages 18 to 65
- Depression assessed through phone screen
- Not currently on antidepressant medications
- 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
You may not qualify if…
- Those with a contraindication for MRIs (e.g. implanted metal)
- Any unstable medical condition
- History of head trauma with loss of consciousness
- History of seizures
- Neurological or uncontrolled medical disease
- Active substance abuse
- Diagnosis of psychotic or bipolar disorder
- A prior history of ECT or rTMS failure
- Currently taking medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
- Currently pregnant or breastfeeding
Where it is running
- Stanford University — Stanford, California, United States
Full record on ClinicalTrials.gov
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