- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562153
fMRI Accelerated TMS Depression
October 14, 2025 updated by: Xiaolong Peng, Medical University of South Carolina
Tracking Brain Imaging Changes in Depression Over Clinical Accelerated Transcranial Magnetic Stimulation (TMS) Therapy at the Individual Level
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.
Study Overview
Status
Recruiting
Conditions
Intervention / 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 Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marion Wood
- Phone Number: 843-792-9502
- Email: woodma@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29429
- Recruiting
- 30 Bee Street
-
Principal Investigator:
- Xiaolong Peng, Ph.D.
-
Contact:
- Marion Wood
- Phone Number: 8437928502
- Email: woodma@musc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Volunteers with diagnosed MDD undergoing accelerated transcranial magnetic stimulation therapy (TMS).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
MRI will be used to observe brain states over time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xiaolong Peng, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2024
Primary Completion (Estimated)
August 5, 2026
Study Completion (Estimated)
August 5, 2026
Study Registration Dates
First Submitted
August 9, 2024
First Submitted That Met QC Criteria
August 19, 2024
First Posted (Actual)
August 20, 2024
Study Record Updates
Last Update Posted (Estimated)
October 16, 2025
Last Update Submitted That Met QC Criteria
October 14, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00138260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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