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Clinical Trials/NCT06562153
NCT06562153
Recruiting
Not Applicable

Tracking Brain Imaging Changes in Depression Over Clinical Accelerated Transcranial Magnetic Stimulation (TMS) Therapy at the Individual Level

Medical University of South Carolina1 site in 1 country20 target enrollmentSeptember 23, 2024
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Medical University of South Carolina
Enrollment
20
Locations
1
Primary Endpoint
Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 23, 2024
End Date
August 5, 2026
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaolong Peng

Research Instructor

Medical University of South Carolina

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

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.

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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