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

NCT ID: NCT06043401

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2026-04-01

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy volunteers

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).

Neuroimaging with Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

MRI will be used to observe brain states over time.

volunteers with Major Depressive Disorder

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).

Neuroimaging with Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

MRI will be used to observe brain states over time.

Interventions

Neuroimaging with Magnetic Resonance Imaging (MRI)

MRI will be used to observe brain states over time.

Intervention Type: OTHER

Eligibility Criteria

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

• 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 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Andrew Manett

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Manett, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00127417

Identifier Type: -

Identifier Source: org_study_id