CClinicalTrials.gg
Active, not recruitingNCT04278521Updated Dec 12, 2025

Mechanism of Action of Transcranial Magnetic Stimulation

An interventional study of Transcranial Magnetic Stimulation in Major Depressive Disorder and Depression, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
  • Registered 8 years 3 months after the study started (first participant enrolled Nov 2011, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Major Depressive Disorder
  • Depression

Keywords

  • Transcranial Magnetic Stimulation
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's enrollment of 54 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
  2. Substance use disorder (abuse or dependence) with active use within the last 3 months
  3. Severe or unstable medical illness.
  4. MRI contraindications as determined by MGH department of radiology.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Other
    Unipolar Depression

    Patients diagnosed with unipolar depression.

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

    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.

    Also known as: TMS

06

What researchers measure

Primary outcomes

  1. Changes in Functional Connectivity of Key Nodes in Depression

    Measured by Magnetic Resonance Imaging

    Time frame: Through Treatment Completion, Average of 6 Weeks

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02129, 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 Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04278521
Lead sponsor
Massachusetts General Hospital
Responsible party
Joan A Camprodon, MD MPH PhD (Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation, Massachusetts General Hospital) — Principal investigator
First posted
Feb 20, 2020
Start date
Nov 2011
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Dec 12, 2025

Study contacts

Joan Camprodon, MD, PhD, MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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