UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034445 |
|---|---|
| Receipt number | 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 | 2021/04/20 14:18:08 |
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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 | 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
oboshi@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
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
| 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
30
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
| 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
| 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=R000039278
