UMIN-CTR Clinical Trial

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
Email	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
Email	n-yasu@n-fukushi.ac.jp

Sponsor
Institute	Nihon Fukushi University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043493