UMIN-CTR Clinical Trial

Basic information
Public title	Abnormal processing of facial expression and perception in neurological disorders and its pathological basis
Acronym	Pathological basis for abnormal facial expression and perception
Scientific Title	Abnormal processing of facial expression and perception in neurological disorders and its pathological basis
Scientific Title:Acronym	Pathological basis for abnormal facial expression and perception
Region	Japan

Condition
Condition	neurological disorders
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to elucidate the pathophysiological basis of abnormal processing of facial expression and perception in various neurological disorders
Basic objectives2	Others
Basic objectives -Others	to study whether treatment used for neurological disorders affects facial processing
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	changes in expresssion associated with medicaltreatmen
Key secondary outcomes	changes in facial muscle activity related to each category of expression, EEG activity associated with performance of facial expression and perception tasks

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	adult neurological patients, age-matched control subjects those who are able to give informed contsent
Key exclusion criteria	For experiments using transcranial magnetic stimulation, patients with severe spinal spondylosis and those with metals inside the head are exlcuded. Patients with cognitive impairment unable to give informed consent and patients with eplilepsy are also excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Terao
Organization	Kyorin University
Division name	Department of Cell Physiology
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	+81422475511
Email	yterao-tky@umin.ac.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name Terao
Organization	Kyorin University
Division name	Kyorin University
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka, Tokyo
TEL	+81422475511
Homepage URL
Email	yterao-tky@umin.ac.jp

Sponsor
Institute	Department of Cell Physiology Kyorin University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Faculty of Medicine Research Ethics Committee, Kyorin University
Address	6-20-2 Shinkawa, Mitaka, Tokyo
Tel	0422-47-511
Email	rec@ks.kyorin-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 03 Month 09 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	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 10 Day
Date of IRB	2018 Year 09 Month 25 Day
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date	2023 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	evaluate facial processing using various neurophysiological measures

Management information
Registered date	2019 Year 03 Month 09 Day
Last modified on	2020 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039350