Closed-loop Optimized rTMS for Depression
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.
Conditions:
🦠 Major Depressive Disorder
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) 1 November 2024
✅ Study Completion (Estimated) 15 November 2024
👥 Enrollment (Estimated) 54
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Stanford, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 October 2019
  • First Submitted that Met QC Criteria 25 October 2019
  • First Posted 29 October 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 December 2023
  • Last Update Posted 6 December 2023
  • Last Verified December 2023