UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063007 |
|---|---|
| Receipt number | R000072121 |
| Scientific Title | Regional differences and mechanisms of cerebral blood flow responses to orthostatic stress: a passive head-up tilt study using near-infrared spectroscopy and electroencephalography |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 09:15:46 |
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Basic information
Public title
Regional differences in brain blood flow during orthostatic stress: a study using passive head-up tilt
Acronym
Regional differences in brain blood flow during orthostatic stress: a study using passive head-up tilt
Scientific Title
Regional differences and mechanisms of cerebral blood flow responses to orthostatic stress: a passive head-up tilt study using near-infrared spectroscopy and electroencephalography
Scientific Title:Acronym
Regional differences and mechanisms of cerebral blood flow responses to orthostatic stress: a passive head-up tilt study using near-infrared spectroscopy and electroencephalography
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify regional differences in cerebral blood flow reduction during orthostatic stress in relation to changes in cortical activity and autonomic function
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanisms of cerebral circulatory regulation during orthostatic stress
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxygenated, deoxygenated, and total hemoglobin concentrations in the bilateral prefrontal cortex, supplementary motor area, and primary motor cortex measured by near-infrared spectroscopy; brain activity in each frequency band measured by electroencephalography
Key secondary outcomes
Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, oxygen uptake, carbon dioxide output, respiratory rate, tidal volume, minute ventilation, end-tidal carbon dioxide, peripheral oxygen saturation, heart rate variability, and total hemoglobin in the gastrocnemius muscle
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Participants with a history of cardiovascular disease, pulmonary disease, and neurological or psychiatric disorder
Participants on drug therapy
Individuals whom the researchers determined to be inappropriate for participation for reasons not specified above
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kojima |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574309
sho-kojima@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kojima |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574309
Homepage URL
sho-kojima@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Institutional Review Board, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata
Tel
0252574455
rinri@nuhw.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 | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2026 | Year | 09 | Month | 21 | 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=R000072121
