UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051457 |
|---|---|
| Receipt number | R000058625 |
| Scientific Title | Effect of environmental light on regional blood flow of the human brain |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/06/27 11:01:37 |
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Basic information
Public title
Effect of environmental light on local blood flow of the human brain
Acronym
Light dark MRI of the human brain
Scientific Title
Effect of environmental light on regional blood flow of the human brain
Scientific Title:Acronym
Light dark MRI of the human brain
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of human brain function using 3D-pseudo-continuous arterial spin labeling 3T MRI under light and dark condition
Basic objectives2
Others
Basic objectives -Others
Measurement of local cerebral blood flow using 3D-pseudo-continuous arterial spin labeling
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of human brain function using 3D-pseudo-continuous arterial spin labeling 3T MRI under light and dark condition to find the statistically significant changes of local cerebral blood flow
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
out-patients complaining of subjective or objective memory decline
Key exclusion criteria
Participants with cognitive decline due to organic pathology (stroke, brain tumors, brain injury, postoperative) were excluded .
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nawashiro |
Organization
Tokorozawa Central Hospital
Division name
Department of Neurosurgery
Zip code
359-0037
Address
3-18-1 Kusunokidai, Tokorozawa, Saitama
TEL
+81-4-2994-1265
hiroshinawashiro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nawashiro |
Organization
Tokorozawa Central Hospital
Division name
Department of Neurosurgery
Zip code
359-0037
Address
3-18-1 Kusunokidai, Tokorozawa, Saitama
TEL
+81-4-2994-1265
Homepage URL
hiroshinawashiro@yahoo.co.jp
Sponsor or person
Institute
Tokorozawa Central Hospital, Department of Neurosurgery
Institute
Department
Personal name
Hiroshi Nawashiro
Funding Source
Organization
Tokorozawa Central Hospital, Department of Neurosurgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Bioinformation and Therapeutic Systems, National Defense Medical College Research Institute
Name of secondary funder(s)
Graduate School of Bio-Applications & Systems Engineering, Tokyo University of Agriculture and Technology
IRB Contact (For public release)
Organization
Tokorozawa Central Hospital IRB
Address
3-18-1 Kusunokidai, Tokorozawa, Saitama
Tel
+81-4-2994-1265
fukushimaset@wafukai.or.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
所沢中央病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 30 | 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
400
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
| 2021 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients
Age
Gender
MMSE
HDS-R
GDS
Cerebral blood flow was quantified by 3D pseudo-continuous arterial spin laleling (3D pCASL) during MRI room lights turned on and off.
All patients underwent 5 minutes of 3D T1WI voxel based morphometry and 5 minutes 3D pCASL during MRI room lights on, and immediately followed by 5 minutes of 3D pCASL during MRI room lights off.
Management information
Registered date
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058625
