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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034445
Receipt No. R000039278
Scientific Title Task-induced brain activity measured by time-resolved spectroscopy
Date of disclosure of the study information 2018/10/15
Last modified on 2019/04/12

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Basic information
Public title Task-induced brain activity measured by time-resolved spectroscopy
Acronym Task-induced brain activity measured by time-resolved spectroscopy
Scientific Title Task-induced brain activity measured by time-resolved spectroscopy
Scientific Title:Acronym Task-induced brain activity measured by 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 the brain activity during the situation imagination task by using time-resolved spectroscopy (TRS), and explore the frontal pole role in the emotion-evoked situation imagination.
Basic objectives2 Others
Basic objectives -Others Brain activity
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Hemoglobin concentration changes
Key secondary outcomes Skin blood flow
Heart rate/Electrodermal activity
Behavioral data

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 autonomic nerve system measurements during the activation task, brain structure measurement (MRI), and psychological test
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
6.Individuals who can undergo MRI test
Key exclusion criteria 1.Individuals who have a history of traumatic brain injury with an unconsciousness lasting more than 5 minutes
2.Individuals who have a history of organic brain disease
3.Individuals who have a history of psychiatric disease
4.Individuals who have a history of substance dependence
5.Individuals who have a history of disorders of consciousness and/or seizure
6.Individuals who have a chronic headache
7. Individuals who have a sleeping disorder
8. Individuals who are not able to keep unmoved
9. Individuals who have a history of cardiovascular disease
10. Individuals who have a history of cervical spine disease, cervical injury and/or neck pain
11. Individuals who are not able to be in a fixed posture for extended period of time by hernia
12.Individuals who have a risk for MRI scan
13. Individuals who have a history of smoking within 48 hours of measurement
14.Individuals who have a history of alcohol and/or caffeine intake within 48 hours of measurement
15.Individuals who have a very narrow forehead for attached probe size
16.Individuals whom examiners judge to be inapplicable for being a subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumi Oboshi
Organization Hamamatsu University School of Medicine
Division name Department of Innovative Medical Photonics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2392
Email oboshi@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Oboshi
Organization Hamamatsu University School of Medicine
Division name Department of Innovative Medical Photonics
Zip code
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 10 Month 15 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
2018 Year 09 Month 26 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 10 Month 22 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
2018 Year 10 Month 11 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039278

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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