UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of nervous disease prediction technology based on measurement of physiological parameters to explain emotion (1: Basic study)
Title of the study (Brief title)	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	Koji Matsuura
Organization	Okayama University
Division name	Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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	Koji Matsuura
Organization	Okayama University
Division name	Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022197