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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028359
Receipt No. R000032467
Scientific Title Study on safety of Transcorneal electrical stimulation for healthy subjects
Date of disclosure of the study information 2017/08/01
Last modified on 2018/04/02

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Basic information
Public title Study on safety of Transcorneal electrical stimulation for healthy subjects
Acronym Study on safety of Transcorneal electrical stimulation for healthy subjects
Scientific Title Study on safety of Transcorneal electrical stimulation for healthy subjects
Scientific Title:Acronym Study on safety of Transcorneal electrical stimulation for healthy subjects
Region
Japan

Condition
Condition volunteer(healthy)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We would like to evaluate the effect of improving disc edema more quickly and improving the visual function by treating with corticosteroid and transcorneal electrical stimulation (TES) for the acute phase of non-arteritic ischemic optic neuropathy ing. The purpose of this research is to confirm the safety of TES which is not insurance-adapted.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in visual function before and after TES use
Key secondary outcomes Changes before and after TES use of pupil, light reaction, visual field, fundus photograph, OCT, papillary retinal blood flow, VEP, PhNR

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Stimulation: The pulse width is 1 ms, the current intensity is 100 mA, stimulation for 30 min at 20 Hz. Regarding the stimulus, while confirming the reaction of the subject, gradually increase the current level from 10 mA.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subjects aged 20 years or older at consent acquisition.
2) Miyazaki University School of Medicine Department of Ophthalmology School's homepage is openly invited to recruit volunteers without optic nerve disease. Pay attention so as not to cause disadvantage in personnel affairs.
3) Participating volunteers shall receive a sufficient explanation for their participation in this research, and shall be subjects who have sufficient understanding and document consent by the volunteer's free will.
Key exclusion criteria 1) Target who judged that the person responsible for implementation was inappropriate as a subject.
2) If you discover an optic nerve disease before starting the study, you will stop participating in the study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Chuuman
Organization University of Miyazaki hospital
Division name Ophthalmology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692
TEL 0985-85-2806
Email hchuman@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Chuuman
Organization University of Miyazaki hospital
Division name Ophthalmology
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692
TEL 0985-85-2806
Homepage URL
Email hchuman@med.miyazaki-u.ac.jp

Sponsor
Institute Ophthalmology, University of Miyazaki hospital
Institute
Department

Funding Source
Organization This research is carried out at the university administration cost of clinical department to which the responsible person belongs, clinical research support expenses.
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 01 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 03 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 25 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032467

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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