Transpalpebral electrical stimulation for the treatment of retinitis pigmentosa: study protocol for a series of N-of-1 single-blind, randomized controlled trial

Trials · 9 authors, 2 centres

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TL;DR

The planned intervention is TpES administered over three cycles of 8-week treatment and control periods.

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The planned intervention is TpES administered over three cycles of 8-week treatment and control periods. The primary outcome is visual field (VF) assessment at multiple timepoints up to week 48. Secondary outcomes include best-corrected visual acuity, optical coherence tomography, fundus autofluorescence, electroretinogram, and vision-related quality of life. The protocol cites a rationale for using the N-of-1 design due to RP's rarity, chronicity, and heterogeneity.

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other

SPECIALTY

ophthalmology

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AI pipeline

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ORIGINAL PAPER

PMC10821291

Transpalpebral electrical stimulation for the treatment of retinitis pigmentosa: study protocol for a series of N-of-1 single-blind, randomized controlled trial

Trials

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ABSTRACT

Abstract Background Retinitis pigmentosa (RP) is an inherited disease characterized by a progressive loss of rod photoreceptors of the eye, leading to irreversible blindness. To date, to our knowledge, no clinical prospective studies have been undertaken that could document the effect of interventions that could reverse or reduce the progression of this disease. The application of microcurrent stimulation (ES) of the eye in the treatment of chronic eye diseases such as glaucoma and age-related macular degeneration has been used over several decades and has been reported to have beneficial effects to reduce the progression of these blinding diseases and has been supported by animal studies and smaller clinical studies, but to date, no large randomized clinical trials on the use of microcurrent therapy have been published. More recent clinical reports have also shown beneficial effects of ES on slowing the progression of RP but also lacks data from robust prospective clinical outcome studies. To our knowledge, this is the first prospective randomized study to evaluate the safety and clinical effectiveness of transpalpebral electrical stimulation (TpES) on the progression of RP. Methods Randomized prospective study using N-of-1 trial 3 single-blind, crossover comparisons. The intervention period of each comparison is divided into treatment period and control period which are randomized arranged. Twelve participants will be strictly recruited in N-of-1 trial by the researcher in accordance with the inclusion and exclusion criteria. The main outcome of interest examined after each cycle of the 8-week intervention period is the assessment of the visual field (VF). Other variables of interest are best corrected visual acuity (BCVA), retinal function using electroretinogram (ERG), and visual function using NEI VFQ-25 questionnaire. Objective assessments of retinal changes will be undertaken using optical coherence tomography (OCT) and fundus autofluorescence (FAF). Discussion The trial will evaluate the efficacy and safety of microcurrent stimulation on RP and provide high-quality evidence for clinical application through N-of-1 trial. Trial registration Chinese Clinical Trial Registry; ChiCTR2300067357; https://www.chictr.org.cn/showproj.html?proj=174635 . Registered on 5 January 2023 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-024-07933-0. Keywords: Transpalpebral electrical stimulation, Microcurrent stimulation, Retinitis pigmentosa, N-of-1 trial

CITATION EXPORT

Wei Zhou, Ziyang Huang, Kai Xu et al.. Transpalpebral electrical stimulation for the treatment of retinitis pigmentosa: study protocol for a series of N-of-1 single-blind, randomized controlled trial. Trials. (2024). https://doi.org/10.1186/s13063-024-07933-0

AUTHORS

9 · 2 CENTRES

Wei Zhou, Ziyang Huang, Kai Xu, Yamin Li, Xiaoyu Li, Jiaxian Li, Yu Jin, Torkel Snellingen, Lina Liang

1Department of Eye Function Laboratory, Eye Hospital, China Academy of Chinese Medical Sciences, Beijing, China
2Beijing Research Institute of Vision Science & Sekwa Eye Hospital, Beijing, China