Brain-Based Biomarkers in Response to TMS in MDD

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843373
• Other study ID #: IRB-25948
• Status: Completed
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• TMS

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMS-EEG	From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity	Up to 3 months