UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on safety of Transcorneal electrical stimulation for healthy subjects
Title of the study (Brief title)	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	Hideki Chuuman
Organization	University of Miyazaki hospital
Division name	Ophthalmology
Address	5200 Kihara, Kiyotake, Miyazaki 889-1692
TEL	0985-85-2806
Email	hchuman@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Hideki Chuuman
Organization	University of Miyazaki hospital
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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