Brain-Based Biomarkers in Response to TMS in MDD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMS

Device

Primary outcomes

TMS-EEG

Time frame: Up to 3 months

From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jul 25, 2016
Registry last updated: Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed