UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063075 |
|---|---|
| Receipt number | R000072204 |
| Scientific Title | Study of Changes in Brain Structure and Function Before and After Magnetic Seizure Therapy (MST) for Treatment-Resistant Depression |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 15:30:56 |
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Basic information
Public title
Study of Changes in Brain Structure and Function Before and After Magnetic Seizure Therapy (MST) for Treatment-Resistant Depression
Acronym
MST Neuroimaging Study
Scientific Title
Study of Changes in Brain Structure and Function Before and After Magnetic Seizure Therapy (MST) for Treatment-Resistant Depression
Scientific Title:Acronym
MST Neuroimaging Study
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize changes in brain structure, brain function, and microstructure before and after magnetic seizure therapy (MST) in patients with treatment-resistant depression, by examining correlations with clinical measures and comparing these changes with those observed before and after electroconvulsive therapy (ECT).
Basic objectives2
Others
Basic objectives -Others
To explore changes in brain structure, brain function, and microstructure following MST and investigate treatment-related neurobiological mechanisms through associations with clinical measures and comparisons with changes following ECT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in MRI-derived brain imaging measures from before to after treatment. Brain structure (gray matter volume, cortical thickness, and subcortical volumes), microstructure (diffusion MRI measures), and brain function (resting-state functional connectivity) will be assessed exploratorily without prespecifying a single imaging measure or brain region.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-contrast MRI will be performed for research purposes. Participants will undergo three 3-T MRI assessments: within 1 month before treatment initiation, within 2 weeks after the final treatment session (excluding the following day), and 6 months (plus or minus 1 month) after enrollment in this imaging study. Participants enrolled at Kyoto University will additionally undergo 7-T MRI before and after treatment. Brain structure, microstructure, and resting-state brain function will be assessed. MRI assessments will take approximately 60-90 minutes per time point and approximately 60 minutes at the 6-month follow-up. MST treatment allocation follows the parent clinical trial, while ECT is provided according to clinical decisions; this imaging study does not allocate treatment. Individuals whose existing data from the C0810 study are used will undergo no additional imaging or intervention.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals meeting one of the following criteria:
1. MST group: Patients with treatment-resistant depression participating in the parent MST trial (MSTD-001), aged 18-80 years at consent for that trial. Both active MST and sham MST groups are included.
2. ECT group: Individuals aged 18 years or older at enrollment in this imaging study who receive clinically indicated ECT for a depressive episode.
3. Depression and healthy participant groups using existing C0810 data: Individuals aged 16 years or older when the data to be used were acquired. Only existing data will be used; no additional examinations will be performed.
Key exclusion criteria
1. Individuals with contraindications to MRI.
2. Individuals with conditions that may substantially affect the assessment of central nervous system structure or function, including neurological disorders, brain tumors, cerebrovascular disease, traumatic brain injury, or neurodegenerative diseases.
3. Individuals whose participation is judged by the investigators to potentially adversely affect their symptoms or health.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Suwa |
Organization
Kyoto University Hospital
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3386
tarosuwa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Suwa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3386
Homepage URL
tarosuwa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
3 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072204
