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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038216
Receipt No. 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 2020/04/08

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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
Email 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
Email oboshi@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
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
2020 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043563

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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