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Active, Not Recruiting

NCT Number: NCT06043401

Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic Stimulation Therapy

This study will attempt to use magnetic resonance imaging (MRI) to take a picture of the brain to learn about changes that occur in the brain during Transcranial Magnetic Stimulation (TMS) in people receiving this treatment for depression.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

The purpose of this study is to take a picture of the participants brain using magnetic resonance imaging (MRI) and then use an investigational way of imaging the brain, called Individualized Network-based Single-frame Coactivation Pattern Estimation ("INSCAPE") to capture the participants brain activity. This method uses a computer program to understand which parts of the participants brain communicate with each other and creates a map of the brain areas that are connected.

The participants may take part in this study either because they are planning to receive Transcranial Magnetic Stimulation ("TMS") for Major Depressive Disorder ("MDD"), or because they are healthy volunteers. If the participants agree to take part in the study, they will attend three experimental visits in which they will undergo MRI scans. The interval between each experimental visits is about 3 weeks. The study itself does not provide TMS treatments, as it is only to attempt to observe the effects of TMS on the brain.

During each experimental visit, the investigators will conduct a brain scan for about 30 minutes in total. During the MRI scan, the participants will need to stay still, relax, and keep eyes open in the scanner. The purpose of this study is to explore whether this investigational brains can protocol, referred to as INSCAPE, can detect brain changes over the course of depression treatment while patients are receiving TMS. This method uses a computer program to understand which parts of the participants brain communicate with each other and creates a map of the brain areas that are connected.

Who can participate

Healthy volunteers accepted: Yes

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

MDD volunteers:

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 other than MDD that would preclude candidacy for TMS.
  • Metal implant devices in the head, heart, or neck.
  • History of brain surgery.
  • History of cortisol medication use or electroconvulsive therapy.
  • History of myocardial infarction or arrhythmia, bradycardia.
  • Personal history of recent 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

Healthy Volunteers Inclusion Criteria

  • Age 18-65
  • Have the capacity and ability to provide one's own consent in English and sign the informed consent document.

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 recent 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. Monitoring brain state renormalization with MRI

    Time frame: Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.

    We will collect 3 MRI over the course of 6 weeks

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: INSCAPE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Apr 20, 2026

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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