DepressionNCT06562153
fMRI Accelerated TMS Depression
An observational study of Depression, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Neuroimaging with Magnetic Resonance Imaging (MRI)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 5 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers with diagnosed MDD undergoing accelerated transcranial magnetic stimulation therapy (TMS).
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
30 Bee Street
Charleston, South Carolina, 29429
Marion Wood, 8437928502, woodma@musc.edu
Xiaolong Peng, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Neuroimaging with Magnetic Resonance Imaging (MRI)
- Keywords
- Brain, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimaging with Magnetic Resonance Imaging (MRI)Other
MRI will be used to observe brain states over time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neuroimaging with Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start23 Sep 2024
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for the Advancement of Clinical TMS
- Responsible party
- Principal investigator, Xiaolong Peng, Medical University of South Carolina
- Investigators
- Xiaolong Peng, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562153
- Sponsor's protocol ID
- Pro00138260
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2024
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Brain Imaging Changes in Depression Over Clinical Accelerated Transcranial Magnetic Stimulation (TMS) Therapy at the Individual Level
- ClinicalTrials.gov ID
- NCT06562153
- Acronym / sponsor ID
- Pro00138260
- Conditions
- Depression
- Keywords
- Brain, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Foundation for the Advancement of Clinical TMS
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer Participants with Major Depressive Disorders (MDD) | – | Other: Neuroimaging with Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with diagnosed MDD undergoing accelerated transcranial magnetic stimulation therapy (TMS).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroimaging with Magnetic Resonance Imaging (MRI)MRI will be used to observe brain states over time. | Other | Volunteer Participants with Major Depressive Disorders (MDD) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaolong Peng principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Wood (843-792-9502, woodma@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.