Study on safety of Transcorneal electrical stimulation for healthy subjects

UMIN ID: UMIN000028359

Registered date:01/08/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: volunteer(healthy)
• Date of first enrollment: 2017/08/10
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Changes in visual function before and after TES use
• Secondary Outcome: Changes before and after TES use of pupil, light reaction, visual field, fundus photograph, OCT, papillary retinal blood flow, VEP, PhNR

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Ophthalmology, University of Miyazaki hospital
• Source(s) of Monetary Support: This research is carried out at the university administration cost of clinical department to which the responsible person belongs, clinical research support expenses.