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

"Declarations Ethics approval and consent to participateThis trial will be in accordance by the Declaration of Helsinki and Ethical Guidelines for Clinical Research. The updated version of trial protocol (version 2.0, 1 December 2022) has been reviewed and approved on 23 December 2022 (YKEC-KT-2022–043-P002) by the ethics committee of Eye Hospital, China Academy of Chinese Medical Sciences, and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the study participants and their legal guardian. The study is in progress. All documents communicating with the ethics committee will be reposited by the principal investigator. Modifications of the protocol will be reviewed by the ethics committee and implemented after approval. Later results will be registered in ChiCTR and made available to participants in accordance with the terms described in the documents. Consent for publicationNot applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding authors. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"Funding This study is supported by the National Natural Science Foundation of China (No.82274589,No.81973912). This study is also supported by the Science and Technology Innovation Project in China Academy of Chinese Medical Sciences (CI2021A02602) and the China Center for Evidence-based Medicine of Traditional Chinese Medicine Special Project for Director of Business Research Office (2020YJSZX-2). These funding bodies do not play any role in the study design, data collecting, management, analysis, interpretation of data, and writing of the report."

"Trial registration Chinese Clinical Trial Registry; ChiCTR2300067357; https://www.chictr.org.cn/showproj.html?proj=174635. Registered on 5 January 2023"