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frequent skin ekectrical stimulation for Leber hereditary optic neuropathy

Clinical study on efficacy and safety of frequent skin ekectrical stimulation for Leber hereditary optic neuropathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052200033
Enrollment
15
Registered
2020-07-06
Start date
2021-08-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber Hereditary Optic Neuropathy

Interventions

skin electrical stimulation

Sponsors

Nakamura Makoto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age:>=16years, =0.01, <0.1

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Improvement rate of LogMAR visual acuity 1 week after final skin electrical stimulation compared to LogMAR visual acuity before electrical skin stimulation

Secondary

MeasureTime frame
(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

Contacts

Public ContactYuko Nakanishi

Kobe University Hospital

yamaday@med.kobe-u.ac.jp+81-78-382-6048

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026