Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy
Abstract Background No effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical s...
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| Language: | English |
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BMC
2023-10-01
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| Series: | Bioelectronic Medicine |
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| Online Access: | https://doi.org/10.1186/s42234-023-00125-2 |
| _version_ | 1797557647405219840 |
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| author | Gen Miura Tadami Fujiwara Yoshihito Ozawa Yuki Shiko Yohei Kawasaki Tomohiro Nizawa Tomoaki Tatsumi Takuji Kurimoto Sotaro Mori Makoto Nakamura Hideki Hanaoka Takayuki Baba Shuichi Yamamoto |
| author_facet | Gen Miura Tadami Fujiwara Yoshihito Ozawa Yuki Shiko Yohei Kawasaki Tomohiro Nizawa Tomoaki Tatsumi Takuji Kurimoto Sotaro Mori Makoto Nakamura Hideki Hanaoka Takayuki Baba Shuichi Yamamoto |
| author_sort | Gen Miura |
| collection | DOAJ |
| description | Abstract Background No effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with NAION. Methods Five patients with monocular NAION underwent TdES (10-ms biphasic pulses, 1.0 mA, 20 Hz, 30 min) of the affected eye six times at 2-week intervals. The primary endpoint was the logarithm of the mini-mum angle of resolution (logMAR) visual acuity at 12 weeks compared with 0 weeks. The secondary endpoints were changes in the best-corrected logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, and mean deviation (MD) of the Humphrey field analyzer (HFA) 10–2 and HFA Esterman test scores. Additionally, the safety of TdES was evaluated. Results LogMAR visual acuity improved by ≥ 0.1 in two eyes, and ETDRS visual acu-ity improved by ≥ 5 characters in one eye. The mean change in logMAR visual acuity from week 0 showed an increasing trend. The mean MD of HFA 10–2 showed no obvious change, while HFA Esterman score improved in four eyes. All patients completed the study according to the protocol, and no treatment-related adverse events were observed. Conclusions TdES treatment may have improved visual acuity and visual field in some patients. Further sham-controlled study in larger cohort is needed on its effectiveness. Trial registration UMIN, UMIN000036220. Registered 15 March, 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041261 . |
| first_indexed | 2024-03-10T17:19:34Z |
| format | Article |
| id | doaj.art-be1808dd2e364f56b331301132481e3c |
| institution | Directory Open Access Journal |
| issn | 2332-8886 |
| language | English |
| last_indexed | 2024-03-10T17:19:34Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Bioelectronic Medicine |
| spelling | doaj.art-be1808dd2e364f56b331301132481e3c2023-11-20T10:23:20ZengBMCBioelectronic Medicine2332-88862023-10-019111010.1186/s42234-023-00125-2Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathyGen Miura0Tadami Fujiwara1Yoshihito Ozawa2Yuki Shiko3Yohei Kawasaki4Tomohiro Nizawa5Tomoaki Tatsumi6Takuji Kurimoto7Sotaro Mori8Makoto Nakamura9Hideki Hanaoka10Takayuki Baba11Shuichi Yamamoto12Department of Ophthalmology and Visual Science, Chiba University Graduate School of MedicineClinical Research Centre, Chiba University HospitalClinical Research Centre, Chiba University HospitalClinical Research Centre, Chiba University HospitalClinical Research Centre, Chiba University HospitalDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of MedicineDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of MedicineDepartment of Surgery, Division of Ophthalmology, Kobe University Graduate School of MedicineDepartment of Surgery, Division of Ophthalmology, Kobe University Graduate School of MedicineDepartment of Surgery, Division of Ophthalmology, Kobe University Graduate School of MedicineClinical Research Centre, Chiba University HospitalDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of MedicineDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of MedicineAbstract Background No effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with NAION. Methods Five patients with monocular NAION underwent TdES (10-ms biphasic pulses, 1.0 mA, 20 Hz, 30 min) of the affected eye six times at 2-week intervals. The primary endpoint was the logarithm of the mini-mum angle of resolution (logMAR) visual acuity at 12 weeks compared with 0 weeks. The secondary endpoints were changes in the best-corrected logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, and mean deviation (MD) of the Humphrey field analyzer (HFA) 10–2 and HFA Esterman test scores. Additionally, the safety of TdES was evaluated. Results LogMAR visual acuity improved by ≥ 0.1 in two eyes, and ETDRS visual acu-ity improved by ≥ 5 characters in one eye. The mean change in logMAR visual acuity from week 0 showed an increasing trend. The mean MD of HFA 10–2 showed no obvious change, while HFA Esterman score improved in four eyes. All patients completed the study according to the protocol, and no treatment-related adverse events were observed. Conclusions TdES treatment may have improved visual acuity and visual field in some patients. Further sham-controlled study in larger cohort is needed on its effectiveness. Trial registration UMIN, UMIN000036220. Registered 15 March, 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041261 .https://doi.org/10.1186/s42234-023-00125-2Nonarteritic anterior ischemic optic neuropathyNAIONElectrical stimulationSkin electrodeTES |
| spellingShingle | Gen Miura Tadami Fujiwara Yoshihito Ozawa Yuki Shiko Yohei Kawasaki Tomohiro Nizawa Tomoaki Tatsumi Takuji Kurimoto Sotaro Mori Makoto Nakamura Hideki Hanaoka Takayuki Baba Shuichi Yamamoto Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy Bioelectronic Medicine Nonarteritic anterior ischemic optic neuropathy NAION Electrical stimulation Skin electrode TES |
| title | Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| title_full | Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| title_fullStr | Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| title_full_unstemmed | Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| title_short | Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| title_sort | efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy |
| topic | Nonarteritic anterior ischemic optic neuropathy NAION Electrical stimulation Skin electrode TES |
| url | https://doi.org/10.1186/s42234-023-00125-2 |
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