Major Depressive DisorderINSCAPENCT06043401
Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic Stimulation Therapy
An observational study of Major Depressive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Neuroimaging with Magnetic Resonance Imaging (MRI)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 1 Apr 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty patients with MDD receiving standard-of-care TMS treatment at the MUSC Brain Stimulation Service will be recruited to participate in this prospective neuroimaging study. No preference will be given based on race, gender, or ethnicity. Pregnant females and children under the age of 18 will be excluded for safety reasons. No vulnerable populations or special classes of subjects will be considered for participation. Twenty healthy controls will be enrolled as a comparison group.
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 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.
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- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Neuroimaging with Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Depressive Disorder, Major
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 |
|---|---|---|
| healthy volunteers | Age and sex-matched healthy individuals will also be recruited as a control group. They will be scanned three times (baseline, 3-week, and 6-week time points). Receives: Other: Neuroimaging with Magnetic Resonance Imaging (MRI) | |
| volunteers with Major Depressive Disorder | 20 patients with MDD receiving standard-of-care depression treatment (TMS) at twill be recruited to participate in this observational neuroimaging study. They will be scanned three times (baseline, 3-week, and 6-week time points). 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.
Monitoring brain state renormalization with MRI
We will collect 3 MRI over the course of 6 weeks
Measured: Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start4 Apr 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Manett, Medical University of South Carolina
- Investigators
- Andrew Manett, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043401
- Sponsor's protocol ID
- Pro00127417
- Acronym
- INSCAPE
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic Stimulation Therapy
- ClinicalTrials.gov ID
- NCT06043401
- Acronym / sponsor ID
- INSCAPE / Pro00127417
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Sep 2023 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: Neuroimaging with Magnetic Resonance Imaging (MRI)Age and sex-matched healthy individuals will also be recruited as a control group. They will be scanned three times (baseline, 3-week, and 6-week time points). |
| volunteers with Major Depressive Disorder | – | Other: Neuroimaging with Magnetic Resonance Imaging (MRI)20 patients with MDD receiving standard-of-care depression treatment (TMS) at twill be recruited to participate in this observational neuroimaging study. They will be scanned three times (baseline, 3-week, and 6-week time points). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients with MDD receiving standard-of-care TMS treatment at the MUSC Brain Stimulation Service will be recruited to participate in this prospective neuroimaging study. No preference will be given based on race, gender, or ethnicity. Pregnant females and children under the age of 18 will be excluded for safety reasons. No vulnerable populations or special classes of subjects will be considered for participation. Twenty healthy controls will be enrolled as a comparison group.
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 (26 listed)
- 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.
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 | healthy volunteers, volunteers with Major Depressive Disorder |
Primary outcome
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
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 20 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrew Manett, MD 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 Major Depressive Disorder, 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 26 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring brain state renormalization with MRI (time frame: Baseline, 3-weeks, and 6-weeks, assessed up to 6 weeks.). 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 20 Apr 2026.