UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036138 |
|---|---|
| Receipt number | R000039350 |
| Scientific Title | Abnormal processing of facial expression and perception in neurological disorders and its pathological basis |
| Date of disclosure of the study information | 2019/03/09 |
| Last modified on | 2020/09/08 17:25:12 |
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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
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
yterao-tky@umin.ac.jp
Sponsor or person
Institute
Department of Cell Physiology
Kyorin University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039350
