Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.

<h4>Objective</h4>This multicenter, randomized, double-blind, placebo-controlled, crossover trial aimed to evaluate whether prolonged noisy galvanic vestibular stimulation improves body balance in patients with vestibulopathy.<h4>Materials and methods</h4>This trial was regis...

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Main Authors: Chisato Fujimoto, Takuya Kawahara, Yayoi S Kikkawa, Makoto Kinoshita, Teru Kamogashira, Mineko Oka, Tsukasa Uranaka, Naoya Egami, Kentaro Ichijo, Kayoko Kabaya, Sachiyo Katsumi, Ikumi Takashima, Yoshiharu Yamamoto, Masato Yagi, Tatsuya Yamasoba, Shinichi Iwasaki
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0317822
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author Chisato Fujimoto
Takuya Kawahara
Yayoi S Kikkawa
Makoto Kinoshita
Teru Kamogashira
Mineko Oka
Tsukasa Uranaka
Naoya Egami
Kentaro Ichijo
Kayoko Kabaya
Sachiyo Katsumi
Ikumi Takashima
Yoshiharu Yamamoto
Masato Yagi
Tatsuya Yamasoba
Shinichi Iwasaki
author_facet Chisato Fujimoto
Takuya Kawahara
Yayoi S Kikkawa
Makoto Kinoshita
Teru Kamogashira
Mineko Oka
Tsukasa Uranaka
Naoya Egami
Kentaro Ichijo
Kayoko Kabaya
Sachiyo Katsumi
Ikumi Takashima
Yoshiharu Yamamoto
Masato Yagi
Tatsuya Yamasoba
Shinichi Iwasaki
author_sort Chisato Fujimoto
collection DOAJ
description <h4>Objective</h4>This multicenter, randomized, double-blind, placebo-controlled, crossover trial aimed to evaluate whether prolonged noisy galvanic vestibular stimulation improves body balance in patients with vestibulopathy.<h4>Materials and methods</h4>This trial was registered in the Japan Pharmaceutical Information Center Clinical Trials Information registry (jRCT1080224083). Subjects were 20- to 85-year-old patients who had been unsteady for more than one year and whose symptoms had persisted despite more than six months of rehabilitation. Enrolled subjects were randomly assigned to one of two groups; one group received the optimal intensity of noisy galvanic vestibular stimulation first and then the placebo 14 days later, the other was evaluated in the reverse order. The primary outcome was the difference of the mean percent change from the baseline in the velocity of center of pressure during 3 h of stimulation between the noisy galvanic vestibular stimulation and placebo periods. This was analyzed with the mixed effects model.<h4>Results</h4>Forty-two subjects were enrolled. The mean percent change in the velocity during stimulation for 3 h was -9.3% (SD 19.9%) for noisy galvanic vestibular stimulation and -12.6% (SD 15.0%) for placebo. No significant effects of noisy galvanic vestibular stimulation over placebo were found for velocity in the least-squares means of the difference [3.1% (95% CI -0.2 to 6.4, p = 0.066)].<h4>Conclusion</h4>Prolonged noisy galvanic vestibular stimulation did not significantly improve body balance in patients with poorly-compensated vestibulopathy.
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spelling doaj-art-6948f6402dc640058ee31bacda97fb5e2025-02-05T05:32:08ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01201e031782210.1371/journal.pone.0317822Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.Chisato FujimotoTakuya KawaharaYayoi S KikkawaMakoto KinoshitaTeru KamogashiraMineko OkaTsukasa UranakaNaoya EgamiKentaro IchijoKayoko KabayaSachiyo KatsumiIkumi TakashimaYoshiharu YamamotoMasato YagiTatsuya YamasobaShinichi Iwasaki<h4>Objective</h4>This multicenter, randomized, double-blind, placebo-controlled, crossover trial aimed to evaluate whether prolonged noisy galvanic vestibular stimulation improves body balance in patients with vestibulopathy.<h4>Materials and methods</h4>This trial was registered in the Japan Pharmaceutical Information Center Clinical Trials Information registry (jRCT1080224083). Subjects were 20- to 85-year-old patients who had been unsteady for more than one year and whose symptoms had persisted despite more than six months of rehabilitation. Enrolled subjects were randomly assigned to one of two groups; one group received the optimal intensity of noisy galvanic vestibular stimulation first and then the placebo 14 days later, the other was evaluated in the reverse order. The primary outcome was the difference of the mean percent change from the baseline in the velocity of center of pressure during 3 h of stimulation between the noisy galvanic vestibular stimulation and placebo periods. This was analyzed with the mixed effects model.<h4>Results</h4>Forty-two subjects were enrolled. The mean percent change in the velocity during stimulation for 3 h was -9.3% (SD 19.9%) for noisy galvanic vestibular stimulation and -12.6% (SD 15.0%) for placebo. No significant effects of noisy galvanic vestibular stimulation over placebo were found for velocity in the least-squares means of the difference [3.1% (95% CI -0.2 to 6.4, p = 0.066)].<h4>Conclusion</h4>Prolonged noisy galvanic vestibular stimulation did not significantly improve body balance in patients with poorly-compensated vestibulopathy.https://doi.org/10.1371/journal.pone.0317822
spellingShingle Chisato Fujimoto
Takuya Kawahara
Yayoi S Kikkawa
Makoto Kinoshita
Teru Kamogashira
Mineko Oka
Tsukasa Uranaka
Naoya Egami
Kentaro Ichijo
Kayoko Kabaya
Sachiyo Katsumi
Ikumi Takashima
Yoshiharu Yamamoto
Masato Yagi
Tatsuya Yamasoba
Shinichi Iwasaki
Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
PLoS ONE
title Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
title_full Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
title_fullStr Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
title_full_unstemmed Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
title_short Multicenter randomized double-blind placebo-controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy.
title_sort multicenter randomized double blind placebo controlled crossover study of the effect of prolonged noisy galvanic vestibular stimulation on posture or gait in vestibulopathy
url https://doi.org/10.1371/journal.pone.0317822
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