UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of neural mechanism of sensory information processing.
Acronym	Investigation of neural mechanism of sensory information processing.
Scientific Title	Investigation of neural mechanism of sensory information processing.
Scientific Title:Acronym	Investigation of neural mechanism of sensory information processing.
Region	Japan

Condition
Condition	Healthy Subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate neural mechanism of various sensory information processing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Brain activity (EEG, fMRI, NIRS) Autonomic nervous activity (hart rate, blood pressure, respiration) Endocrine system (salivary biomarker)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food Device,equipment
Interventions/Control_1	Various sensory stimulation (gustation, olfaction, audition, visual transduction, somatic sensation).
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy subjects who can provide informed consent.
Key exclusion criteria	Subjects who are recognised as unsuitable by investigators. (Conditions in fMRI experiment) 1) Subjects who have metal in the body (ex. A pacemaker, aneurysm clip). 2) Subjects who have some diseases such as ischemic heart disease and epilepsy caused by paroxysm. 3) Subjects with severe claustrophobia. 4) Subjects who are difficult to communicate with the experimenters during experiment. 5) Subjects with deficient thermoregulation (dyshydrosis, heart disease). 6) Subjects who are pregnant or possibility of pregnancy.
Target sample size	140

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kouich Takamoto
Organization	University of Toyama
Division name	Department of Judo Neurophysiotherapy
Zip code
Address	2630,Sugitani, Toyama, Japan
TEL	076-434-7217
Email	ktakamo@med.u-toyama.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kouich Takamoto
Organization	University of Toyama
Division name	Department of Judo Neurophysiotherapy
Zip code
Address	2630,Sugitani, Toyama, Japan
TEL	076-434-7217
Homepage URL
Email	ktakamo@med.u-toyama.ac.jp

Sponsor
Institute	Department of Judo Neurophysiotherapy, University of Toyama, Graduate school of medicine and pharmaceutical science,
Institute
Department

Funding Source
Organization	Japan Judo Therapist Association
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	2011 Year 08 Month 25 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	2011 Year 07 Month 22 Day
Date of IRB	2006 Year 08 Month 23 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 08 Month 16 Day
Last modified on	2019 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=R000007302