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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name