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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028935
Receipt No. R000033066
Scientific Title Examination of the improvement of mood disorders in Parkinson's disease by the deformed facial feedback
Date of disclosure of the study information 2017/08/31
Last modified on 2019/09/03

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Basic information
Public title Examination of the improvement of mood disorders in Parkinson's disease by the deformed facial feedback
Acronym SMILE PROJECT
Scientific Title Examination of the improvement of mood disorders in Parkinson's disease by the deformed facial feedback
Scientific Title:Acronym SMILE PROJECT
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine "a sensational mirror", which developed in University of Tokyo,Department of engineering Hirose, Tanikawa laboratory, improve the mood disorders of patients with Parkinson's diseaase.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.The Positive and Negative Affect Schedule:J-PANAS
2.Emotinal Sensitivity Task
3.heart rate change
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
Other
Interventions/Control_1 Exposure to deformed facial feedback
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 The patients with Parkinson's disease whose Hoehn & Yahr stage are lower than grade III
Key exclusion criteria patients with wearing-off
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Osada
Organization Keio University, School of Medicine
Division name Department of Neurology
Zip code
Address 35 Shinanomachi shinjuku-ku,Tokyo
TEL 0353633788
Email takashiosada@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Tanikawa
Organization Keio University, School of Medicine
Division name Department of Neurology
Zip code
Address 35 Shinanomachi shinjuku-ku,Tokyo
TEL 0353633788
Homepage URL
Email marikotanikawa@keio.jp

Sponsor
Institute Keio University, School of Medicine
Department of Neurology
Institute
Department

Funding Source
Organization Keio University, School of Medicine
Department of Neurology
Organization
Division
Category of Funding Organization Other
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
2017 Year 08 Month 31 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 Terminated
Date of protocol fixation
2016 Year 05 Month 06 Day
Date of IRB
2018 Year 03 Month 31 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 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
2017 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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