UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060957 |
|---|---|
| Receipt number | R000069757 |
| Scientific Title | Dynamic changes in total hemoglobin concentration in the frontal region during motion-based video gameplay in patients with Duchenne muscular dystrophy: A pilot study using portable near-infrared spectroscopy (NIRS) |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/17 10:16:35 |
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Basic information
Public title
Study on Brain Activity During Video Game Play in Duchenne Muscular Dystrophy
Acronym
DMD Brain-Game Study
Scientific Title
Dynamic changes in total hemoglobin concentration in the frontal region during motion-based video gameplay in patients with Duchenne muscular dystrophy: A pilot study using portable near-infrared spectroscopy (NIRS)
Scientific Title:Acronym
DMD Frontal NIRS Study
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Pediatrics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in total hemoglobin concentration in the prefrontal cortex from rest to motion-based video game play in patients with DMD using portable NIRS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total hemoglobin concentration in the prefrontal cortex
Key secondary outcomes
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
| 7 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
Male patients with DMD aged elementary school age or older who are undergoing outpatient rehabilitation at our university hospital.
Key exclusion criteria
Patients were excluded if they had previously played the game used in this study, had color blindness, or were unable to read color names.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Okano |
Organization
Shinshu University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263372413
satoka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Okano |
Organization
Shinshu University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263372413
Homepage URL
satoka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Research Ethics Committee for Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
Tel
0263373099
mdrinri@shinshu-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 | 03 | Month | 23 | 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
9
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study without intervention. Prefrontal total hemoglobin concentration will be measured using portable near-infrared spectroscopy (NIRS) during rest and motion-based video game play in patients with DMD.
Management information
Registered date
| 2026 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069757
