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NCT Number: NCT06562153

fMRI Accelerated TMS Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

30 Bee Street

Charleston, South Carolina, 29429, United States

Location status: Recruiting

Location contact

Marion Wood

CONTACT

[email protected]

8437928502

Xiaolong Peng, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuroimaging with Magnetic Resonance Imaging (MRI)

Other

MRI will be used to observe brain states over time.

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Marion Wood

CONTACT

[email protected]

843-792-9502

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Foundation for the Advancement of Clinical TMS

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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