UMIN-CTR Clinical Trial

Basic information
Public title	Study of the interaction between sensory organs and the central nervous system
Acronym	Study of the interaction between sensory organs and the central nervous system
Scientific Title	Study of the interaction between sensory organs and the central nervous system
Scientific Title:Acronym	Study of the interaction between sensory organs and the central nervous system
Region	Japan

Condition
Condition	Non
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the development of stereoscopic image display device based on the human visual characteristics , We study the interaction between sensory organs and the central nervous system.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurements of fMRI during visual stimulation
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	Other
Interventions/Control_1	visual sense stimulation
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 person
Key exclusion criteria	Non
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naruhiko Terano
Organization	Saitama Medical University Hospital
Division name	Neurosurgery
Zip code
Address	38, Morohongo, Moroyama-machi Iruma-gun, Saitama, Japan
TEL	049-276-1334
Email	terano@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naruhiko Terano
Organization	Saitama Medical University Hospital
Division name	Neurosurgery
Zip code
Address	38, Morohongo, Moroyama-machi Iruma-gun, Saitama, Japan
TEL	049-276-1334
Homepage URL
Email	terano@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Hitachi, Ltd
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 11 Month 19 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	2015 Year 11 Month 19 Day
Date of IRB	2015 Year 11 Month 19 Day
Anticipated trial start date	2015 Year 11 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 18 Day
Last modified on	2020 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022908