A study on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy
- Conditions
- eber hereditary optic neuropathy
- Registration Number
- JPRN-jRCTs052180066
- Lead Sponsor
- Kurimoto Takuji
- Brief Summary
In the present study, we have demonstrated that repeated application of SES led to significant improvements in both visual acuity and visual fields in 10 cases of LHON with the mtDNA 11778 mutation that otherwise rarely shows spontaneous recovery. Moreover, none of the 10 cases experienced any of the predicted SES-related adverse events or discontinued therapy because of skin irritation. Our data, therefore, indicate that SES has the potential to be an effective and safe treatment for patients with LHON.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 11
(1) Patients with ages ranging from 16 and 80 years of age.
(2) Patients who are diagnosed as having Leber hereditary optic neuropathy
(3) Patients who provide written informed consent. In cases under 20 years, informed consent must be obtained from both patients themselves and guardians.
(4) Patients with the disease more than 8 months since onset without visual improvement.
(5) Patients with a missense mutation of mtDNA at the positon 11778.
(6) Patients who show best corrected decimal visual acuity less than 0.1.
(1) Patients who had smoked until the last half of year
(2)Patients with implantable electronic devices such as cardiac pacemakers etc.
(3)Patients with a history of intraocular surgery within the past a year
(4)Patients with other eye diseases except for an incipient cataract and a pseudophakic eye
(5) Patients who is on going idebenone treatment or within 1 year after the discontinuance
(6)Patients who use either ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, antiretroviral drugs, amiodarone, infliximab, clioquinol, dapsone, quinine, pheniprazine, suramin sodium, or isoniazid.
(7)Patients with a history of epilepsy
(8)Pregnant individuals
(9)Patients with severe allergic diseases including atopic dermatitis
(10)Patients participating in other clinical studies
(11)Patients judged inappropriate for other research responsible doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The averaged difference of the LogMAR between before SES and 1 week after the last skin electrical stimulation session.
- Secondary Outcome Measures
Name Time Method Efficacy outcome measures <br>logMAR (4 and 8 weeks after the last SES treatments), HVF (1,4 and 8 weeks after the last SES treatments), CFF (1,4 and 8 weeks after the last SES treatments), color test (Standard Pseudoisochromatic Plates Part 2 for Aquired Color Vision Defects)(8 weeks after the last SES treatments), Optical coherence tomography (8 weeks after the last SES treatments), Microperimetry (MP-3)(8 weeks after the last SES treatments), multifocal VEP(8 weeks after the last SES treatments) <br>Safety outcome measures <br>The slit lamp biomicroscopy, fundus examination, intraocular pressure, specular microscope, observation of skin condition (photo finish), other adverse events