UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038216 |
|---|---|
| Receipt number | R000043563 |
| Scientific Title | Cerebral blood flow measurement during a creative activity using a time-resolved spectroscopy |
| Date of disclosure of the study information | 2019/10/10 |
| Last modified on | 2021/04/20 14:19:40 |
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Basic information
Public title
Cerebral blood flow measurement during a creative activity using a time-resolved spectroscopy
Acronym
Cerebral blood flow measurement during a creative activity using a time-resolved spectroscopy
Scientific Title
Cerebral blood flow measurement during a creative activity using a time-resolved spectroscopy
Scientific Title:Acronym
Cerebral blood flow measurement during a creative activity using a time-resolved spectroscopy
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether the pleasurable creative activity enhances the prefrontal activation by measuring cerebral blood flow change using time-resolved spectroscopy (TRS).
Basic objectives2
Others
Basic objectives -Others
Cerebral blood flow change
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemoglobin concentration changes
Key secondary outcomes
Heart rate
Visual Analogue Scale value of Subjective Investigation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
TRS and heart rate measurement during the task, and subjective investigation
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy participants (20 years or over to less than 30 years)
2.Individuals who are native speaker of Japanese
3.Individuals who are right-handed
4.Individuals who are consent to participate in this study
5.Individuals whose normal or corrected vision are over 0.7
Key exclusion criteria
1.Individuals with a history of traumatic brain injury with an unconsciousness lasting more than 5 minutes
2.Individuals with a history of organic brain disease
3.Individuals with a past or current history of psychiatric disease
4.Individuals with a history or current symptom of substance dependence
5.Individuals with a history of disordered consciousness and/or seizure
6.Individuals with chronic headache
7.Individuals with sleeping disorder
8.Individuals who are not able to keep unmoved
9. Individuals with a past or current history of cardiovascular disease
10. Individuals who are not able to stay in one position for a long time (about 15 minutes) because of low back pain
11.Individuals who smoke within 48 hours before the measurement
12.Individuals who feel bad at or dislike composition activity using
screw-block
13.Individuals who have a disability in finger dexterity movement (on both hands) after an injury such as bone fracture or other reasons
14.Individuals who are considered unsuitable by researchers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuyuki |
| Middle name | |
| Last name | Nagafusa |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Division of Rehabilitation
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2747
nagafusa@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Oboshi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Innovative Medical Photonics
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2392
Homepage URL
oboshi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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
HASHIMOTO RASHI CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2019 | Year | 10 | Month | 10 | 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
24
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2021 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043563
