UMIN-CTR Clinical Trial

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
Institute	Nihon University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037866