Mechanism of Action of Transcranial Magnetic Stimulation

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04278521
Collaborator
(none)
54
1
1
144
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mechanism of Action of Transcranial Magnetic Stimulation
Actual Study Start Date :
Nov 1, 2011
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Unipolar Depression

Patients diagnosed with unipolar depression.

Device: 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.
Other Names:
  • TMS
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Functional Connectivity of Key Nodes in Depression [Through Treatment Completion, Average of 6 Weeks]

      Measured by Magnetic Resonance Imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    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:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02129

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Joan Camprodon, MD, PhD, MPH, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    ClinicalTrials.gov Identifier:
    NCT04278521
    Other Study ID Numbers:
    • 2014P001835
    First Posted:
    Feb 20, 2020
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022