UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033215
Receipt number R000037866
Scientific Title Research on Executive Function of Nursing Home Residents:Consideration of EEG during a Flanker Task
Date of disclosure of the study information 2018/06/30
Last modified on 2020/07/20 09:54:29

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Basic information

Public title

Research on Executive Function of Nursing Home Residents:Consideration of EEG during a Flanker Task

Acronym

Research on Executive Function of Nursing Home Residents

Scientific Title

Research on Executive Function of Nursing Home Residents:Consideration of EEG during a Flanker Task

Scientific Title:Acronym

Research on Executive Function of Nursing Home Residents

Region

Japan


Condition

Condition

Mild Cognitive Impairment,Dementia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

As a movement period is prolonged, much of the senior citizen who moves into a welfare facility of senior citizen in the whole country can't also ignore a social burden from the current state I come to hold cognitive impairment and a large number of problems with which. Because the danger shifted to recognition shou is very high for a senior citizen with Mild Cognitive Impairment in particular, the early detection is important. So handy results of a reaction time test and relation between that case's EEG and MCI are considered by this research.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG

Key secondary outcomes

Flanker Task
Geriatric Depression Scale
TimedUpandGotest
Grip
TMIG IndexofCompetence
Montreal Cognitive Assessment
Mini-Mental State Examination


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

75 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

More than 75-year-old senior citizen who moves into a nursing home

Key exclusion criteria

Person with visual disorder and high cognitive impairment

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Taiki
Middle name
Last name Komatsu

Organization

Nihon University

Division name

College of Sports Science

Zip code

154-8513

Address

3-34-1 Shimouma, Setagaya-ku, TOKYO 154-8513 JAPAN.

TEL

03-6453-1766

Email

komatsu.taiki@nihon-u.ac.jp


Public contact

Name of contact person

1st name Taiki
Middle name
Last name Komatsu

Organization

Nihon University

Division name

College of Sports Science

Zip code

154-8513

Address

3-34-1 Shimouma, Setagaya-ku, TOKYO 154-8513 JAPAN.

TEL

03-6453-1766

Homepage URL


Email

komatsu.taiki@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University

Institute

Department

Personal name



Funding Source

Organization

Nihon University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon UNIV

Address

Setagaya Shimouma 3-34-1

Tel

0364531600

Email

sunakawa.ryousuke@nihon-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

2018 Year 06 Month 30 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

Completed

Date of protocol fixation

2017 Year 05 Month 29 Day

Date of IRB

2016 Year 09 Month 01 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The problem executive function is measured using flanker task. flanker task is a program on the PC, and a line of 5 arrows is presented on the monitor, and a button which corresponds for the one of the central target arrow which is soon is pressed as fast as possible. The congruent condition that both of a target and flanker are the same suitable arrow and 2 conditions of the target and the incongruent condition that flanker is arrows for the opposite are set as a target as combination of flanker presented around it. This is made 1 try, and 1 per 4 seconds is the pace of the try, and total of 120 try is put into effect. That time's EEG are measured.EEG make the two earlobe a reference, and gauge two earlobe combination with low-frequency cutoff 0.016Hz and high pass frequency cutoff 70Hz in the standard from Fp1,Fp2,F3,F4,F7,F8,C3,C4,T3,T4,Fz,Cz,Pz ,P1,P2,O1,O2. Its tendency is analyzed from an analysis of EEG by this, and because some problems occur to the thing which considers whether a gauge of MCI can be clarified and problem execution, the MCI level, a daily life function decline, the body function and a depressed state are considered from the hypothesis fall generates. When the validity of the cognitive problem is obtained, it'll be made a trying study about the relation with the body activity in the future.


Management information

Registered date

2018 Year 06 Month 30 Day

Last modified on

2020 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name