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Mechanism of Action of Transcranial Magnetic Stimulation

Primary Purpose

Major Depressive Disorder, Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Unipolar Depression

Arm Description

Patients diagnosed with unipolar depression.

Outcomes

Primary Outcome Measures

Changes in Functional Connectivity of Key Nodes in Depression
Measured by Magnetic Resonance Imaging

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
March 2, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04278521
Brief Title
Mechanism of Action of Transcranial Magnetic Stimulation
Official Title
Mechanism of Action of Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression
Keywords
Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unipolar Depression
Arm Type
Other
Arm Description
Patients diagnosed with unipolar depression.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Functional Connectivity of Key Nodes in Depression
Description
Measured by Magnetic Resonance Imaging
Time Frame
Through Treatment Completion, Average of 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PhD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mechanism of Action of Transcranial Magnetic Stimulation

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