Mechanism of Action of Transcranial Magnetic Stimulation

NCT ID: NCT04278521

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Major Depressive Disorder Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unipolar Depression

Patients diagnosed with unipolar depression.

Group Type OTHER

Transcranial Magnetic Stimulation

Intervention Type 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.

Interventions

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Transcranial 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.

Intervention Type DEVICE

Other Intervention Names

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TMS

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Camprodon, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2014P001835

Identifier Type: -

Identifier Source: org_study_id

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