UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038412 |
|---|---|
| Receipt number | R000043772 |
| Scientific Title | Study on the area difference of the habituation of the cerebral activity by using near-infrared spectroscopy |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2022/05/09 15:49:41 |
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Basic information
Public title
Study on the area difference of the habituation of the cerebral activity by using near-infrared spectroscopy
Acronym
Study on the area difference of the habituation of the cerebral activity by using near-infrared spectroscopy
Scientific Title
Study on the area difference of the habituation of the cerebral activity by using near-infrared spectroscopy
Scientific Title:Acronym
Study on the area difference of the habituation of the cerebral activity by using near-infrared spectroscopy
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Psychiatry | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the utility of Stroop task as the habituation-tolerant neurocognitive task as near-infrared spectroscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cerebral activity from the first examination
Key secondary outcomes
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Check the amount of the cerebral habituation by comparing the first and second Stroop 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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
The person who has neuropsychiatric diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University, Faculty of Medicine School of Health Sciences
Division name
Department of Rehabilitation
Zip code
3718514
Address
3-39-22, Showa-machi, Maebashi city, Gunma-pref.
TEL
0272207111
senichiro@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University, Faculty of Medicine School of Health Sciences
Division name
Department of Rehabilitation
Zip code
3718514
Address
3-39-22, Showa-machi, Maebashi city, Gunma-pref.
TEL
0272207111
Homepage URL
senichiro@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University, Faculty of Medicine School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa-machi, Maebashi city, Gunma-pref.
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000043772&flwp_key=1005DorglkI
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000043772&flwp_key=1005DorglkI
Number of participants that the trial has enrolled
13
Results
In both the Stroop task and the word fluency task, there was a decrease in brain activity near the left middle temporal gyrus after two consecutive thoughts. However, since these areas were not the focus of attention in each task, they were not considered to interfere significantly with the test.
Results date posted
| 2021 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Volunteers
Participant flow
Participants underwent two kinds of examination. Each examination was performed a series of two times consecutively to check the habituation of the brain activity
Adverse events
None
Outcome measures
fNIRS waveforms to be said to reflect the participant's brain activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment was terminated after obtaining data on addtional 13 cases due to infectious diseases. The analysis showed satisfactory results.
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
