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Clinical Trials/NCT04278521
NCT04278521Active, not recruitingNot Applicable

Mechanism of Action of Transcranial Magnetic Stimulation

Massachusetts General Hospital1 site in 1 country54 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
54
Locations
1
Primary Endpoint
Changes in Functional Connectivity of Key Nodes in Depression

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Unipolar Depression

Other

Patients diagnosed with unipolar depression.

Intervention: Transcranial Magnetic Stimulation (Device)

Outcomes

Primary Outcomes

Changes in Functional Connectivity of Key Nodes in Depression

Time Frame: Through Treatment Completion, Average of 6 Weeks

Measured by Magnetic Resonance Imaging

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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