UMIN-CTR Clinical Trial

Basic information
Public title	Electrophysiological evaluation of the contribution of color information to face processing by magnetoencephalography and electroencephalography
Acronym	Electrophysiological evaluation of the contribution of color information to face processing by magnetoencephalography and electroencephalography
Scientific Title	Electrophysiological evaluation of the contribution of color information to face processing by magnetoencephalography and electroencephalography
Scientific Title:Acronym	Electrophysiological evaluation of the contribution of color information to face processing by magnetoencephalography and electroencephalography
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the influence of color information on face processing by recording and evaluating the neural activities in human visual pathways using electromagnetic recording
Basic objectives2	Others
Basic objectives -Others	To investigate the influence of color information on face-selective neural activities (N170/M170)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amplitude and latency of N170/M170
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	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Visual stimuli are presented, and brain activities to the stimuli are recorded by electroencephalography/magnetoencephalography.
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	1. Healthy adults 2. Right-handed 3. People who agree to participate in this study
Key exclusion criteria	1. History of neurological disorders 2. Some sort of abnormality in visual system 3. People who are contraindicated for MRI 4. People who are deemed to be ineligible by researcher
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shozo Middle name Last name Tobimatsu
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Clinical Neurophysiology
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, Fukuoka, Japan
TEL	092-642-5543
Email	tobi@neruophy.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Takeda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Clinical Neurophysiology
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, Fukuoka, Japan
TEL	092-642-5543
Homepage URL
Email	takinori@med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Grant-in-Aid for JSPS Fellows
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Comittee of Kyushu University
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka City, Fukuoka, Japan
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-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	2019 Year 02 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	56
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	2019 Year 02 Month 19 Day
Date of IRB	2019 Year 02 Month 19 Day
Anticipated trial start date	2019 Year 02 Month 25 Day
Last follow-up date	2020 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	2019 Year 02 Month 23 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040977