fMRI Accelerated TMS Depression

NCT06562153 | Recruiting

• 1 other identifier: Pro00138260
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

Conditions

Depression

Keywords

Brain; Depression

Outcome Measures

Primary Outcomes (1)

• Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline

  Two magnetic resonance imaging (MRI) scans will be collected at baseline and after the course of 5-day TMS treatment. A neuroimaging analysis method called "INSCAPE" will be used to get the dynamic brain state from the MRI data. The changes in brain states between baseline and after treatment MRI data will be calculated as the outcome measure.

  5 days

Study Arms (1)

Volunteer Participants with Major Depressive Disorders (MDD)

20 patients with MDD receiving 5-day accelerated transcranial magnetic stimulation therapy (TMS) from the clinic will be recruited to participate in this observational neuroimaging study. Participants will undergo two fMRI scans at baseline and post-treatment.

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.

Volunteer Participants with Major Depressive Disorders (MDD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers with diagnosed MDD undergoing accelerated transcranial magnetic stimulation therapy (TMS).

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
• 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 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Foundation for the Advancement of Clinical TMS: collaborator

Study Sites (1)

30 Bee Street

Charleston, South Carolina, 29429, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Neuroimaging; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaolong Peng

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Wood

CONTACT

843-792-9502; woodma@musc.edu

Study Design

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

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 20, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Locations

US (1)