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A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy

Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harb...

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Autores principales: Kurimoto, Takuji, Ueda, Kaori, Mori, Sotaro, Kamada, Seiko, Sakamoto, Mari, Yamada-Nakanishi, Yuko, Matsumiya, Wataru, Nakamura, Makoto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290509/
https://www.ncbi.nlm.nih.gov/pubmed/32384676
http://dx.doi.org/10.3390/jcm9051359
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author Kurimoto, Takuji
Ueda, Kaori
Mori, Sotaro
Kamada, Seiko
Sakamoto, Mari
Yamada-Nakanishi, Yuko
Matsumiya, Wataru
Nakamura, Makoto
author_facet Kurimoto, Takuji
Ueda, Kaori
Mori, Sotaro
Kamada, Seiko
Sakamoto, Mari
Yamada-Nakanishi, Yuko
Matsumiya, Wataru
Nakamura, Makoto
author_sort Kurimoto, Takuji
collection PubMed
description Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harboring the mtDNA 11,778 mutation. Of the 11 enrolled patients, 10 completed six sessions of SES once every two weeks over a 10-week period. The primary outcome measure was the change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA) at one week after the last session of SES. The main secondary outcome measures were the logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities at one, four, and eight weeks. At all follow-up points, the logMAR BCVA had improved significantly from baseline, [1.80 (1.70–1.80) at baseline, 1.75 (1.52–1.80) at one week, 1.75 (1.50–1.80) at four weeks, and 1.75 (1.52–1.80) at eight weeks; p < 0.05]. At eight weeks of follow-up, five patients showed >2-fold increase in the summed sensitivity at 52 measurement points from baseline. No adverse effects were observed. In conclusion, SES could be a viable treatment option for patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation.
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spelling pubmed-72905092020-06-17 A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy Kurimoto, Takuji Ueda, Kaori Mori, Sotaro Kamada, Seiko Sakamoto, Mari Yamada-Nakanishi, Yuko Matsumiya, Wataru Nakamura, Makoto J Clin Med Article Leber hereditary optic neuropathy (LHON) is an intractable disease associated with mitochondrial DNA (mtDNA) mutations. In this preliminary, single-arm, prospective, open-label exploratory trial, we investigated the effectiveness and safety of skin electrical stimulation (SES) for cases of LHON harboring the mtDNA 11,778 mutation. Of the 11 enrolled patients, 10 completed six sessions of SES once every two weeks over a 10-week period. The primary outcome measure was the change in logarithm of the minimum angle of resolution (logMAR)-converted best-corrected visual acuity (BCVA) at one week after the last session of SES. The main secondary outcome measures were the logMAR BCVA at four and eight weeks and Humphrey visual field test sensitivities at one, four, and eight weeks. At all follow-up points, the logMAR BCVA had improved significantly from baseline, [1.80 (1.70–1.80) at baseline, 1.75 (1.52–1.80) at one week, 1.75 (1.50–1.80) at four weeks, and 1.75 (1.52–1.80) at eight weeks; p < 0.05]. At eight weeks of follow-up, five patients showed >2-fold increase in the summed sensitivity at 52 measurement points from baseline. No adverse effects were observed. In conclusion, SES could be a viable treatment option for patients with LHON in the chronic phase harboring the mtDNA 11,778 mutation. MDPI 2020-05-06 /pmc/articles/PMC7290509/ /pubmed/32384676 http://dx.doi.org/10.3390/jcm9051359 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kurimoto, Takuji
Ueda, Kaori
Mori, Sotaro
Kamada, Seiko
Sakamoto, Mari
Yamada-Nakanishi, Yuko
Matsumiya, Wataru
Nakamura, Makoto
A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title_full A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title_fullStr A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title_full_unstemmed A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title_short A Single-Arm, Prospective, Exploratory Study to Preliminarily Test Effectiveness and Safety of Skin Electrical Stimulation for Leber Hereditary Optic Neuropathy
title_sort single-arm, prospective, exploratory study to preliminarily test effectiveness and safety of skin electrical stimulation for leber hereditary optic neuropathy
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290509/
https://www.ncbi.nlm.nih.gov/pubmed/32384676
http://dx.doi.org/10.3390/jcm9051359
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