Brain-Based Biomarkers in Response to TMS in MDD



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:3/28/2019
Start Date:July 2016
End Date:December 2022
Contact:Corey Keller, MD PhD
Email:ckeller1@stanford.edu

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

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.

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.

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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Amit Etkin, MD PhD
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mi
from
Palo Alto, CA
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