frequent skin ekectrical stimulation for Leber hereditary optic neuropathy

JRCT ID: jRCTs052200033

Registered date:06/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Leber Hereditary Optic Neuropathy
• Date of first enrollment: 16/08/2021
• Target sample size: 15
• Study type: Interventional
• Intervention(s): skin electrical stimulation

Outcome(s)

• Primary Outcome: Improvement rate of LogMAR visual acuity 1 week after final skin electrical stimulation compared to LogMAR visual acuity before electrical skin stimulation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nakamura Makoto