Targeting Brain Networks to Improve Depression Treatment
CRCNS US-France Research Proposal: Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neuromodulation in Depression
This study is testing whether a personalized brain treatment can help people with major depression feel better by targeting specific brain areas more effectively than standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05224063 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of personalized repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC) and central executive network (CEN) in patients with major depressive disorder. By employing a randomized, double-blind, cross-over design, the study aims to assess whether individualized rTMS can enhance network modulation compared to standard rTMS. A total of 50 participants aged 18-65 will be enrolled, and their CEN connectivity will be evaluated to optimize treatment outcomes. The goal is to improve remission rates for depression, which are currently suboptimal.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 65 with a current diagnosis of major depressive disorder and a PHQ9 score greater than 10.
Not a fit: Patients with a history of neurological disorders, seizures, 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 lead to more effective and personalized treatments for patients suffering from major depressive disorder.
How similar studies have performed: While rTMS has been established as a treatment for depression, this personalized approach targeting the CEN is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women, ages 18 to 65 * Depression assessed through in-depth Structured Clinical Interview for DMS-5 (SCID-I) * PHQ9 \> 10 for disease severity * 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 24 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: kellerlab@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.