fMRI Accelerated TMS Depression

Recruiting

• Conditions: Depression
• Interventions: Other: Neuroimaging with Magnetic Resonance Imaging (MRI)

• Registration Number: NCT06562153
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-20
• Status Verified: 2024-09
• Study Start: 2024-09-23
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Primary Completion: 2026-08-05
• Study Completion: 2026-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volunteer Participants with Major Depressive Disorders (MDD)	Neuroimaging with Magnetic Resonance Imaging (MRI)	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.

Primary Outcome Measures

Name	Time	Method
Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline	5 days	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.

Trial Locations

Locations (1)

30 Bee Street; 🇺🇸 Charleston, South Carolina, United States