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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019322
Receipt No. R000022197
Scientific Title Development of nervous disease prediction technology based on measurement of physiological parameters to explain emotion (1: Basic study)
Date of disclosure of the study information 2015/10/20
Last modified on 2017/04/17

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Basic information
Public title Development of nervous disease prediction technology based on measurement of physiological parameters to explain emotion (1: Basic study)
Acronym nervous disease prediction technology based on physiological parameters
Scientific Title Development of nervous disease prediction technology based on measurement of physiological parameters to explain emotion (1: Basic study)
Scientific Title:Acronym nervous disease prediction technology based on physiological parameters
Region
Japan

Condition
Condition Dementia in future
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By physiological parameter measurement, we will evaluate kinetic change of emotion from unease state to ease state.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Questionnairie: Quality of Life (QOL) assesment and contents evaluation using Visual Analog Scale (VAS)

EEG, EMG, ECG
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Polygraph
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

Not applicable
Gender Male and Female
Key inclusion criteria Self-active person
Key exclusion criteria Patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsuura
Organization Okayama University
Division name Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address Tsushima-naka 3-1-1 Kita-ku, Okayama, Japan
TEL 086-251-8610
Email kojimatu@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsuura
Organization Okayama University
Division name Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address Tsushima-naka 3-1-1 Kita-ku, Okayama, Japan
TEL 086-251-8610
Homepage URL
Email kojimatu@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Nanotech Bank
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 13 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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