UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062971 |
|---|---|
| Receipt number | R000071932 |
| Scientific Title | MRI-Based Evaluation of the Descending Pain Modulation System Using Proton Magnetic Resonance Spectroscopy and Resting-State Functional MRI in Healthy Adults |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/09/18 11:11:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
MRI-Based Evaluation of the Descending Pain Modulation System Using Proton Magnetic Resonance Spectroscopy and Resting-State Functional MRI in Healthy Adults
Acronym
DPM Evaluation Study
Scientific Title
MRI-Based Evaluation of the Descending Pain Modulation System Using Proton Magnetic Resonance Spectroscopy and Resting-State Functional MRI in Healthy Adults
Scientific Title:Acronym
DPM-MRI Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This observational study aims to establish an MRI-based evaluation method for the descending pain modulation (DPM) system by combining magnetic resonance spectroscopy (MRS) and resting-state functional MRI (fMRI) in healthy adult volunteers. Brain metabolite concentrations and functional connectivity within DPM-related brain regions will be evaluated, and same-day test-retest MRI measurements will be performed to assess the reproducibility and stability of these imaging biomarkers.
Basic objectives2
Others
Basic objectives -Others
Development and reproducibility assessment of an MRI-based evaluation method for the descending pain modulation system
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Glx and GABA concentrations, and the Glx/GABA ratio, measured by MRS in predefined regions of interest (anterior cingulate cortex, thalamus, and insular cortex)
2.Resting-state functional connectivity indices among predefined descending pain modulation network regions (anterior cingulate cortex, thalamus, insular cortex, dorsolateral prefrontal cortex, medial prefrontal cortex, amygdala, and spinal dorsal horn)
Key secondary outcomes
1.Test-retest reproducibility of MRS-derived metabolic indices
2.Test-retest reproducibility of resting-state functional connectivity measures
3.Association between MRS-derived metabolic indices and resting-state functional connectivity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy male adults aged 18 to 35 years
2.Right-handed individuals
3.Individuals capable of providing written informed consent
4.Individuals deemed eligible for participation by the investigators
Key exclusion criteria
1.A history of serious neurological, psychiatric, cardiovascular, respiratory, or other disorders, or any such disorder currently requiring treatment
2.A history of organic brain disease
3.Substance dependence
4.Use of medications, supplements, or health foods that may affect brain function or metabolism
5.Contraindications to MRI, including metallic implants, pacemakers, or tattoos
6.Severe claustrophobia
7.Individuals deemed unsuitable for participation by the principal investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yuhei |
| Middle name | |
| Last name | Takado |
Organization
National Institutes for Quantum Science and Technology
Division name
Institute for Quantum Life Science
Zip code
2638555
Address
Anagawa 4-9-1, Inage-ku, Chiba city
TEL
043-251-2111
takado.yuhei@qst.go.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Ono |
Organization
National Institutes for Quantum Science and Technology
Division name
Institite for Quantum Life Science
Zip code
2638555
Address
Anagawa 4-9-1, Inage-ku, Chiba
TEL
0433797093
Homepage URL
takado.yuhei@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Yuhei Takado
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ono Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Certified Review Board of the National Institutes for Quantum Science and Technology
Address
Anagawa 4-9-1, Inage-ku, Chiba
Tel
043-206-4706
helsinki@qst.go.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 | 25 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 07 | Month | 31 | Day |
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071932
