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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06043401
Other study ID # Pro00127417
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 4, 2023
Est. completion date April 4, 2025

Study information

Verified date September 2023
Source Medical University of South Carolina
Contact Andrew J Manett, MD
Phone 8438762003
Email manett@musc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will attempt to use magnetic resonance imaging (MRI) to take a picture of the brain to learn about changes that occur in the brain during Transcranial Magnetic Stimulation (TMS) in people receiving this treatment for depression.


Description:

The purpose of this study is to take a picture of the participants brain using magnetic resonance imaging (MRI) and then use an investigational way of imaging the brain, called Individualized Network-based Single-frame Coactivation Pattern Estimation ("INSCAPE") to capture the participants brain activity. This method uses a computer program to understand which parts of the participants brain communicate with each other and creates a map of the brain areas that are connected. The participants may take part in this study either because they are planning to receive Transcranial Magnetic Stimulation ("TMS") for Major Depressive Disorder ("MDD"), or because they are healthy volunteers. If the participants agree to take part in the study, they will attend three experimental visits in which they will undergo MRI scans. The interval between each experimental visits is about 3 weeks. The study itself does not provide TMS treatments, as it is only to attempt to observe the effects of TMS on the brain. During each experimental visit, the investigators will conduct a brain scan for about 30 minutes in total. During the MRI scan, the participants will need to stay still, relax, and keep eyes open in the scanner. The purpose of this study is to explore whether this investigational brains can protocol, referred to as INSCAPE, can detect brain changes over the course of depression treatment while patients are receiving TMS. This method uses a computer program to understand which parts of the participants brain communicate with each other and creates a map of the brain areas that are connected.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 4, 2025
Est. primary completion date April 4, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility MDD volunteers: Inclusion Criteria - Age 18-65 - Have the capacity and ability to provide one's own consent in English and sign the informed consent document. - DSM-IV diagnosis of MDD Exclusion Criteria - Unable to speak English. - Contraindicated for MRI. - Any current or recent untreated medical, neurological, or psychiatric conditions other than MDD that would preclude candidacy for TMS. - Metal implant devices in the head, heart, or neck. - History of brain surgery. - History of cortisol medication use or electroconvulsive therapy. - History of myocardial infarction or arrhythmia, bradycardia. - Personal history of recent head injury, concussion, or self-report of moderate to severe traumatic brain injury. - Individuals suffering from frequent/severe headaches. - Moderate to severe alcohol or substance use disorder. - Pregnancy Healthy Volunteers Inclusion Criteria - Age 18-65 - Have the capacity and ability to provide one's own consent in English and sign the informed consent document. Exclusion Criteria - Unable to speak English. - Contraindicated for MRI. - Any current or recent untreated medical, neurological, or psychiatric conditions - Metal implant devices in the head, heart, or neck. - History of brain surgery. - History of cortisol medication use or electroconvulsive therapy. - Comorbidity with other psychiatric/neurological illnesses or personality disorders - History of myocardial infarction or arrhythmia, bradycardia. - Personal history of recent head injury, concussion, or self-report of moderate to severe traumatic brain injury. - Individuals suffering from frequent/severe headaches. - Moderate to severe alcohol or substance use disorder. - Pregnancy

Study Design


Intervention

Other:
Neuroimaging with Magnetic Resonance Imaging (MRI)
MRI will be used to observe brain states over time.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Monitoring brain function with MRI We will collect 3 MRI over the course of 6 weeks Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.
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