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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
