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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02843373
Enrollment
54
Registered
2016-07-25
Start date
2016-03-31
Completion date
2019-12-31
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Major Depressive Disorder

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.

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.

Interventions

DEVICETMS

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TMS-EEGUp to 3 monthsFrom pre- to post-treatment, improvement will be based on enhanced excitability and connectivity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026