Unique ID issued by UMIN | UMIN000031057 |
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Receipt number | R000035434 |
Scientific Title | An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2020/08/02 10:07:03 |
An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy
A clinical trial of skin electrical stimulation for Leber hereditary optic neuropathy
An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy
A clinical trial of skin electrical stimulation for Leber hereditary optic neuropathy
Japan |
Leber hereditary optic neuropathy
Ophthalmology |
Others
NO
Leber hereditary optic neuropathy (LHON) is a disease, in which retinal ganglion cells falls into apoptotic cell death due to mainly one of three point mutations of mitochondrial DNA (mtDNA) at nucleotide positions 3460, 11778, 14484, characterized by acute or subacute vision loss of bilateral eyes with an inter-eye time lag in predominantly young males of second to fourth decade of life. Since LHON causes serious impairment of the central vision bilaterally and no effective treatment has been established, the development of a novel therapeutic approach is urgent. We will conduct an exploratory clinical trial to examine the effectiveness and safety of electric stimulation using skin electrical stimulation (SES) device for the improvement of the visual dysfunction in LHON patients. The clinical significance will be extremely high if the improvement of visual function is obtained by SES that can be easily and safely carried out.
Efficacy
Exploratory
Not applicable
LogMAR visual acuity at 1 week after six consecutive skin electrical stimulation (once every two weeks for 10 weeks).
1. LogMAR visual acuity at 4 and 8 week after six consecutive skin electrical stimulation (once a week for 6 weeks).
2. Mean deviation and pattern standard deviation in Humphrey static visual field test (center 30-2, stimulus size 3 or 5), Foveal threshold value, total, the number of 1% and 5% of probability plot with pattern deviation
3. The value of critical fusion frequency
4. Color vision test (standard Pseudoisochromatic Plates Part 2 for Aquired Color Vision Defects (SPP-2))
5. Thickness of peripapillary retinal nerve fiber and macular retinal ganglion cell complex detected by optical coherence tomography
6. The sensitivity of central visual field detected by Micrometry (MP-3)
7. The amplitude of visual evoked potential (Multifocal VEP)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
1
Treatment
Device,equipment |
Skin electrical stimulation (SES), The number of intervention is six times (single SES every two weeks for 10 weeks)
16 | years-old | <= |
80 | years-old | > |
Male and Female
Inclusion criteria
Subjects should fulfill all conditions as follows:
1. Patients with ages ranging from 16 and 80 years of age.
2. Patients who provide written informed consent. In cases under 20 years, informed consent must be obtained from both patients themselves and guardians.
3. Patients with the disease more than 8 months since onset without visual improvement.
4. Patients with a missense mutation of mtDNA at the positon 11778.
5. Patients who show best corrected decimal visual acuity less than 0.1.
Exclusion criteria
Patients who have at least one condition as below will be excluded.
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 the eyes with incipient cataract or intraocular lens
5. Patients who use idebenone and have past history of administration of idebenone within 1 year
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
11
1st name | |
Middle name | |
Last name | Takuji Kurimoto |
Kobe University Graduate School of Medicine
Ophthalmology
7-5-2 Kusunoki-cho Chuo-ku Kobe
078-382-5111
kuri1201@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Takuji Kurimoto |
Kobe University Graduate School of Medicine
Ophthalmology
7-5-2 Kusunoki-cho Chuo-ku Kobe
078-382-5111
kuri1201@med.kobe-u.ac.jp
Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine
Other
NO
2018 | Year | 04 | Month | 01 | Day |
Published
11
Main results already published
2018 | Year | 03 | Month | 20 | Day |
2018 | Year | 03 | Month | 20 | Day |
2018 | Year | 03 | Month | 28 | Day |
2019 | Year | 09 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 01 | Month | 30 | Day |
2020 | Year | 08 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035434
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