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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022193
Receipt No. R000025564
Scientific Title Development of glass-type wearable for diagnosis and therapy for neurodegenerative diseases
Date of disclosure of the study information 2016/05/06
Last modified on 2019/02/28

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Basic information
Public title Development of glass-type wearable for diagnosis and therapy for neurodegenerative diseases
Acronym Development of glass-type wearable for neurodegenerative diseases
Scientific Title Development of glass-type wearable for diagnosis and therapy for neurodegenerative diseases
Scientific Title:Acronym Development of glass-type wearable for neurodegenerative diseases
Region
Japan

Condition
Condition Neurodegenerative diseases
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of diagnostic and therapeutic algorithm for neurodegenerative diseases with glass-type wearable
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Information of extraocular movements and body-axis balance
Key secondary outcomes

Base
Study type Observational

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
40 years-old <=
Age-upper limit
60 years-old >=
Gender Male
Key inclusion criteria 1) Men from 40 to 60 years old.
2) Able to walk without assists.
3) Visual acuity=> 0.7 of each eye.
4) After having sufficient explanation, he/she agree with joining in this research with his/her informed consent
Key exclusion criteria 1) Need to have glassess or contact lens for activity of daily living
2) Severe demented persons (=< 15 of Mini Mentl State Examinations)
3) inappropriate persons that principle investigators decided.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Saiki
Organization Juntendo University
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo Bunkyo
TEL 81-3-3813-3111
Email ssaiki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Saiki
Organization Juntendo University
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo Bunkyo
TEL 81-3-3813-3111
Homepage URL
Email ssaiki@juntendo.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Self-sustaining fund
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 05 Month 06 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
2016 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blink speed/frequency, extraocular movements and body-axis angular velocity/acceleration using glass-type wearable with microsensor and electromyography are calculated. These data are sent to PD with Bluetooth and transferred to Microsoft-EXCEL.

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025564

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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