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Active, Not Recruiting

NCT Number: NCT04278521

Mechanism of Action of Transcranial Magnetic Stimulation

This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

About this study

This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar depression receiving TMS. Patients will be scanned before and after a full course of TMS and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of TMS at the circuit level (2) to study the use of fcMRI as a state biomarker for depression (3) to study the use of fcMRI as a predictor of response for depression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females between the ages of 18-80
  • DSM-IV diagnosis of Depressive Episode
  • Patients requiring TMS treatment as part of their psychiatric care

Exclusion criteria

  • Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
  • Substance use disorder (abuse or dependence) with active use within the last 3 months
  • Severe or unstable medical illness.
  • MRI contraindications as determined by MGH department of radiology.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.

Other names: TMS

Primary outcomes

  1. Changes in Functional Connectivity of Key Nodes in Depression

    Time frame: Through Treatment Completion, Average of 6 Weeks

    Measured by Magnetic Resonance Imaging

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2020
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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