Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic Stimulation Therapy

Active, not recruiting

• Conditions: Major Depressive Disorder
• Interventions: Other: Neuroimaging with Magnetic Resonance Imaging (MRI)

• Registration Number: NCT06043401
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Neuroimaging with Magnetic Resonance Imaging (MRI)	Age and sex-matched healthy individuals will also be recruited as a control group. They will be scanned three times (baseline, 3-week, and 6-week time points).
volunteers with Major Depressive Disorder	Neuroimaging with Magnetic Resonance Imaging (MRI)	20 patients with MDD receiving standard-of-care depression treatment (TMS) at twill be recruited to participate in this observational neuroimaging study. They will be scanned three times (baseline, 3-week, and 6-week time points).

Primary Outcome Measures

Name	Time	Method
Monitoring brain state renormalization with MRI	Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.	We will collect 3 MRI over the course of 6 weeks

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States