Brain-Based Biomarkers in Response to TMS in MDD

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.

Study Overview

• Status: Completed
• Conditions: Depression; Major Depressive Disorder
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community care clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMS-EEG	From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity	Up to 3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Corey Keller, MD PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: IRB-25948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO