UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028359 |
|---|---|
| Receipt number | 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 18:02:25 |
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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
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
hchuman@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Ophthalmology, University of Miyazaki hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032467
