Mechanism of Action of Transcranial Magnetic Stimulation

Mechanism of Action of Transcranial Magnetic Stimulation

Sponsors

Lead Sponsor: Massachusetts General Hospital

Source Massachusetts General Hospital
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.

Overall Status Recruiting
Start Date November 2011
Completion Date November 2023
Primary Completion Date November 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Functional Connectivity of Key Nodes in Depression Through Treatment Completion, Average of 6 Weeks
Enrollment 54
Condition
Intervention

Intervention Type: Device

Intervention Name: Transcranial Magnetic Stimulation

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.

Arm Group Label: Unipolar Depression

Other Name: TMS

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Joan Camprodon, MD, PhD, MPH Principal Investigator Massachusetts General Hospital
Overall Contact

Last Name: Christopher Funes, MS

Phone: 6177248780

Email: [email protected]

Location
Facility: Status: Contact: Massachusetts General Hospital Christopher Funes, MS 617-724-8780 [email protected]
Location Countries

United States

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts General Hospital

Investigator Full Name: Joan A Camprodon, MD MPH PhD

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

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Unipolar Depression

Type: Other

Description: Patients diagnosed with unipolar depression.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov