CClinicalTrials.gg
CompletedNCT02843373Updated Jun 23, 2022

Brain-Based Biomarkers in Response to TMS in MDD

An observational study in Major Depressive Disorder and Depression, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Major Depressive Disorder
  • Depression
03

In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 54 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Community care clinic

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceTMS
06

What researchers measure

Primary outcomes

  1. TMS-EEG

    From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity

    Time frame: Up to 3 months

07

Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02843373
Lead sponsor
Stanford University
Responsible party
Corey Keller (Assistant Professor of Psychiatry and Behavioral Sciences, Stanford University) — Principal investigator
First posted
Jul 25, 2016
Start date
Mar 2016
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Jun 23, 2022

Study contacts

Corey Keller, MD PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion