UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022193 |
|---|---|
| Receipt number | 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 07:25:20 |
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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
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
ssaiki@juntendo.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025564
