Closed-loop Optimized rTMS for Depression

Recruiting

I'm Interested

Trial ID: NCT04142320

Purpose

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.

Official Title

Randomized, Cross-over, Placebo-controlled Trial to Determine Target Engagement and Dose Response of Optimized Closed-loop rTMS for Medication-resistant Depression

Stanford Investigator(s)

Eligibility

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

Intervention(s):

device: closed-loop rTMS

device: open-loop rTMS

device: sham rTMS

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jade Truong