Brain-Based Biomarkers in Response to TMS in MDD

  • STATUS
    Recruiting
  • End date
    Dec 23, 2022
  • participants needed
    100
  • sponsor
    Stanford University
Updated on 23 February 2022
depression
seizure
antidepressants
depressed mood
transcranial magnetic stimulation

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.

Details
Condition Major Depressive Disorder, Depression
Treatment TMS
Clinical Study IdentifierNCT02843373
SponsorStanford University
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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