UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038188 |
|---|---|
| Receipt number | R000043493 |
| Scientific Title | A comparative study of brain activation responses during free and structured tasks using fNIRS |
| Date of disclosure of the study information | 2019/10/02 |
| Last modified on | 2019/10/02 18:37:19 |
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Basic information
Public title
A comparative study of brain activation responses during free and structured tasks using fNIRS
Acronym
A comparative study of brain activation responses during free and structured tasks using fNIRS
Scientific Title
A comparative study of brain activation responses during free and structured tasks using fNIRS
Scientific Title:Acronym
A comparative study of brain activation responses during free and structured tasks using fNIRS
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of free composition tasks and brain activity during composition tasks in healthy subjects using fNIRS
Basic objectives2
Others
Basic objectives -Others
Evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cerebral blood flow
Key secondary outcomes
Modified The Tinkertoy Test
Oxford Schizotypal Personality Scale
Peters et Delusion Inventory
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
There is no obstacle to physical function
There is no obstacle in upper limb function
Neuromuscular disease, no history of surgical treatment for upper limbs and trunk
Key exclusion criteria
fNIRS worn and not determined to be possible
When the skin condition is not suitable for fNIRS (extreme dryness, damage, skin symptoms, etc.)
Left-handed
What did not get consent from the person
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
Faculty of Health Science
Zip code
475-0012
Address
26-2,Higashihaemi-cho,Handa-city,Aichi-pref
TEL
0569-20-0131
n-yasu@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
Faculty of Health Science
Zip code
475-0012
Address
26-2,Higashihaemi-cho,Handa-city,Aichi-pref
TEL
0569-20-0131
Homepage URL
n-yasu@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Nihon Fukushi University
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
Nihon Fukushi University
Address
26-2,Higashihaemi-cho,Handa-city,Aichi-pref
Tel
0569-20-0131
n-yasu@n-fukushi.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 | 02 | 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
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 26 | 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
fNIRS data, modified version of the Tinkertoy Tet, schizophrenia tendency, and paranoid data.
Management information
Registered date
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043493
