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

NCT06043401 | Active Not Recruiting

• 1 other identifier: Pro00127417
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Monitoring brain state renormalization with MRI

  We will collect 3 MRI over the course of 6 weeks

  Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.

Study Arms (2)

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).

Other: Neuroimaging with Magnetic Resonance Imaging (MRI)

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).

Other: Neuroimaging with Magnetic Resonance Imaging (MRI)

Interventions

Neuroimaging with Magnetic Resonance Imaging (MRI) OTHER

MRI will be used to observe brain states over time.

healthy volunteers; volunteers with Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients with MDD receiving standard-of-care TMS treatment at the MUSC Brain Stimulation Service will be recruited to participate in this prospective neuroimaging study. No preference will be given based on race, gender, or ethnicity. Pregnant females and children under the age of 18 will be excluded for safety reasons. No vulnerable populations or special classes of subjects will be considered for participation. Twenty healthy controls will be enrolled as a comparison group.

You may qualify if:

• 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

You may not qualify if:

• 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
• Age 18-65
• Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
• Unable to speak English.
• Contraindicated for MRI.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Neuroimaging; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Andrew Manett, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 21, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)