A study on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy

JRCT ID: jRCTs052180066

Registered date:18/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Leber hereditary optic neuropathy
• Date of first enrollment: 07/05/2018
• Target sample size: 11
• Study type: Interventional
• Intervention(s): The participants will receive six consecutive SES treatments once every two weeks for 10 weeks. The instrument to be used in delivering the treatments is produced by the Mayo corporation. Participants will notice the phosphene elicited by the SES procedure. The threshold current of phosphene is defined as the level of current such that participants can experience phosphene in the entire visual field. After determining this threshold the participant will be treated by using the following SES protocol: the biphasic square wave, 1 mA amplitude, 10 ms duration, 20Hz frequency, for a duration of 30 minutes.

Outcome(s)

• Primary Outcome: The averaged difference of the LogMAR between before SES and 1 week after the last skin electrical stimulation session.

Secondary Outcome

Efficacy outcome measures
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)
Safety outcome measures
The slit lamp biomicroscopy, fundus examination, intraocular pressure, specular microscope, observation of skin condition (photo finish), other adverse events

Key inclusion & exclusion criteria

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

Include criteria

(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.

Exclude criteria

(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

Related Information

• Primary Sponsor: Kurimoto Takuji
• Secondary Sponsor: Nakamura Makoto
• Secondary ID(s): UMIN000031057