UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056723 |
|---|---|
| Receipt number | R000064716 |
| Scientific Title | Cognitive function and brain activity using near-infrared spectroscopy (NIRS) |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2026/01/22 11:43:29 |
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Basic information
Public title
Cognitive function and brain activity using near-infrared spectroscopy (NIRS)
Acronym
Cognitive function and brain activity using near-infrared spectroscopy (NIRS)
Scientific Title
Cognitive function and brain activity using near-infrared spectroscopy (NIRS)
Scientific Title:Acronym
NIRSCFB
Region
| Japan |
Condition
Condition
Right-handed normal subjects and outpatients and inpatients
Classification by specialty
| Medicine in general | Cardiology | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of changes in blood flow and oxygenation in specific regions of the brain.
Basic objectives2
Others
Basic objectives -Others
Barthel Index is assessed by the healthcare provider and the individual themselves to examine the relationship.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Near-infrared spectroscopy (NIRS)
Key secondary outcomes
Barthel Index (medical and personal assessment), International Standardized Physical Activity Questionnaire
WHOQOL, WHODAS, frailty and quality of life and objective performance, polygraph
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
HDS-R measured and non-dementia group (more than 21 points)
Interventions/Control_2
HDS-R Suspected dementia group (less than 20 points)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
right-handedness
Key exclusion criteria
left handed
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
Department of Rehabilitation
Zip code
500-8523
Address
Asahi University Hospital, 3-23 Hashimoto, Gifu, Gifu
TEL
058-253-8001
21dr01@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital,
Division name
Department of Rehabilitation
Zip code
500-8523
Address
Asahi University Hospital, 3-23 Hashimoto, Gifu, Gifu
TEL
058-253-8001
Homepage URL
21dr01@g.seirei.ac.jp
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Asahi University Hospital
Address
Hashimoto, Gifu, Gifu
Tel
058-253-8001
21dr01@g.seirei.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
| 2025 | Year | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2028 | Year | 01 | 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
| 2025 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064716
