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NCT04278521 Clinical Trial

Mechanism of Action of Transcranial Magnetic Stimulation

Depression Clinical Trial

Official title:
Mechanism of Action of Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04278521
Other study ID # 2014P001835
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date April 1, 2025

Study information
Verified date March 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 54
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Functional Connectivity of Key Nodes in Depression Measured by Magnetic Resonance Imaging Through Treatment Completion, Average of 6 Weeks
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