Closed-loop Optimized rTMS for Depression
NCT04142320
Summary
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.
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
Conditions2
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NCT04142320