frequent skin ekectrical stimulation for Leber hereditary optic neuropathy

Phase 3

Recruiting

• Conditions: eber Hereditary Optic Neuropathy

• Registration Number: JPRN-jRCTs052200033
• Lead Sponsor: akamura Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

(1) Age:>=16years, <=80years
(2) Diagnosed as LHON
(3) More than 8 months have passed since onset without visual inprovement
(4) Having the missense mutation of mtDNA at the position 11778
(5) Best corrected decimal visual acuity >=0.01, <0.1

Exclusion Criteria

(1) Best corrected decimal visual acuity <0.01
(2) A history if smoking within 1 year
(3) A history of the implantation of electronic devices such as cardiac pacemakers etc.
(4) A history of inraocular surgery within the past 1 year.
(5) A history of other eye diseases.
(6) Idebenone treatment within 1 year
(7) Treatment with Ethanbutol, chloramphenicol, linezolid, erythromycin, streptomycin, anti-retrovirus drug, amiodarone, infliximab, clioquinol etc.
(8) A history of epilepsy
(9) pregnancy
(10) Severe allergic diseases including atopic dermatitis
(11) Participating in other clinical studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement rate of LogMAR visual acuity 1 week after final skin electrical stimulation compared to LogMAR visual acuity before electrical skin stimulation

Secondary Outcome Measures

Name	Time	Method
(1) Time course of LogMAR visual acuity after electrical skin stimulation<br>(2) Time course of visual field after electrical skin stimulation<br>(3) Time course of Critical Flicker Frequency after electrical skin stimulation<br>(4) Time course of papillocircum retinal nerve fiber thickness and macular retinal ganglion cell complex thickness by optical coherence tomography after electrical skin stimulation<br>(5) Corneal endothelial cell density before and after electrical skin stimulation<br>(6) Safety during electrical skin stimulation