Active — Not RecruitingNot Applicable

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

United States40 participantsStarted 2023-04-04

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Monitoring brain state renormalization with MRI

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

Trial details

NCT IDNCT06043401

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-01

View on ClinicalTrials.gov More Major Depressive Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.