RECRUITING

Closed-loop Optimized rTMS for Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-06-01
Study Completion:2024-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04142320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women, ages 18 to 65
  2. * Depression assessed through phone screen
  3. * Not currently on antidepressant medications
  4. * Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
  5. * Right-handed
  6. * No current or history of neurological disorders
  7. * No seizure disorder or risk of seizures
  8. * No use of PRN medication within 48 hours of the scheduled study appointment
  1. * Those with a contraindication for MRIs (e.g. implanted metal)
  2. * Any unstable medical condition
  3. * History of head trauma with loss of consciousness
  4. * History of seizures
  5. * Neurological or uncontrolled medical disease
  6. * Active substance abuse
  7. * Diagnosis of psychotic or bipolar disorder
  8. * A prior history of ECT or rTMS failure
  9. * Currently taking medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
  10. * Currently pregnant or breastfeeding

Contacts and Locations

Study Contact

Corey Keller, MD, PhD
CONTACT
(650) 498-9111
ckeller1@stanford.edu

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

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

Study Start Date2021-06-01
Study Completion Date2024-11-15

Study Record Updates

Study Start Date2021-06-01
Study Completion Date2024-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder