Cargando…
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...
Autores principales: | , , , , , , , |
---|---|
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 |
_version_ | 1783545693225353216 |
---|---|
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. |
format | Online Article Text |
id | pubmed-7290509 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT kurimototakuji asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT uedakaori asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT morisotaro asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT kamadaseiko asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT sakamotomari asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT yamadanakanishiyuko asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT matsumiyawataru asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT nakamuramakoto asinglearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT kurimototakuji singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT uedakaori singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT morisotaro singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT kamadaseiko singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT sakamotomari singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT yamadanakanishiyuko singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT matsumiyawataru singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy AT nakamuramakoto singlearmprospectiveexploratorystudytopreliminarilytesteffectivenessandsafetyofskinelectricalstimulationforleberhereditaryopticneuropathy |