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

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 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


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

Value
https://center6.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