Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain-Based Biomarkers in Response to TMS in MDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843373
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University

Brief Summary:
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.

Condition or disease Intervention/treatment
Major Depressive Disorder Depression Device: TMS

Detailed Description:

Goals of the study are as follows:

  • To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
  • To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
  • To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder
Study Start Date : July 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
rTMS
rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered to the left DLPFC as assessed by either the 5cm rule or F3 site. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects.
Device: TMS



Primary Outcome Measures :
  1. TMS-EEG [ Time Frame: Up to 3 months ]
    From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community care clinic
Criteria

Inclusion Criteria:

  • Men and women, ages 18 to 60
  • Medication-resistant depression as assessed by psychiatrist
  • Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
  • Has failed >1 previous adequate antidepressant medication trials
  • 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:

  • Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
  • Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
  • Currently pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843373


Contacts
Layout table for location contacts
Contact: Corey Keller, MD PhD ckeller1@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Corey Keller, MD PhD       ckeller1@stanford.edu   
Principal Investigator: Amit Etkin, MD PhD         
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Amit Etkin, MD PhD Stanford University
Additional Information:
Layout table for additonal information
Responsible Party: Alan Schatzberg, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02843373    
Other Study ID Numbers: IRB-25948
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders