Personalized brain stimulation for treating depression
Randomized, Cross-over, Placebo-controlled Trial to Determine Target Engagement and Dose Response of Optimized Closed-loop rTMS for Medication-resistant Depression
This study is testing a personalized brain stimulation treatment for people with depression who haven't found relief from medication to see if it works better than standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04142320 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for patients with medication-resistant major depressive disorder by developing a personalized treatment approach. It will utilize real-time biomarker monitoring to optimize stimulation patterns tailored to individual patients, moving away from the traditional one-size-fits-all method. The trial will involve a four-phase, cross-over, double-blind, placebo-controlled design to assess the efficacy of both standard and optimized rTMS treatments. The ultimate goal is to improve remission rates and deepen the understanding of brain plasticity in relation to depression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who are experiencing major depressive disorder and are not currently on antidepressant medications.
Not a fit: Patients with a history of seizures, neurological disorders, or those currently taking medications that lower seizure thresholds may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with medication-resistant depression.
How similar studies have performed: While rTMS has been FDA-approved for depression, this personalized approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Corey Keller, MD, PhD
- Email: ckeller1@stanford.edu
- Phone: (650) 498-9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.