Mariana Misawa, Inci Yaman Bajin, Bill Zhang, Monica Daibert-Nido, Danielle Tchao, Eduardo Garcia-Giler, Kyle Cheung, Lora Appel, Pi Nasir, Arun Reginald, Uri Tabori, Ute Bartels, Vijay Ramaswamy, Samuel N Markowitz, Eric Bouffet, Michael Reber
{"title":"一项改善儿童和青少年偏视并发脑肿瘤患者视觉感知的远程康复计划:单臂可行性和概念验证试验。","authors":"Mariana Misawa, Inci Yaman Bajin, Bill Zhang, Monica Daibert-Nido, Danielle Tchao, Eduardo Garcia-Giler, Kyle Cheung, Lora Appel, Pi Nasir, Arun Reginald, Uri Tabori, Ute Bartels, Vijay Ramaswamy, Samuel N Markowitz, Eric Bouffet, Michael Reber","doi":"10.1016/j.eclinm.2024.102955","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Brain tumor in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and quality of life, yet no effective intervention exists for this pediatric population. This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to improve visual function and functional vision.</p><p><strong>Methods: </strong>In a phase 2a, open-labeled, nonrandomized, single-arm study, conducted from July 2022 to October 2023 (NCT05065268), 10 children and adolescents with stable hemianopia were enrolled to perform 20-min sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring adoption, adherence and completion rates, remote data transfer and qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were conducted pre- and post-intervention, with follow-ups at 1- and 6 months.</p><p><strong>Findings: </strong>The home-based 3D-MOT-IVR intervention proved both feasible and safe, with no reported adverse events. All participants completed the prescribed stimulations and the pre- and post-intervention assessment points, 90% completed the follow-ups. Nine out of ten participants showed clinically meaningful enhancement in visual function and/or functional vision, namely binocular visual field restoration and increased reading speed, but two showed concomitant deterioration in monocular visual field. These positive effects were sustained at the 6-month follow-up. Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual perception at the binocular visual field test.</p><p><strong>Interpretation: </strong>Our findings underscore the feasibility and safety of home-based audiovisual stimulation in immersive virtual-reality as a potential intervention for improving visual perception in children/adolescents with hemianopia consecutive to a pediatric brain tumor. These promising results lay a strong foundation for a larger randomized controlled trial, offering hope for a meaningful breakthrough in visual rehabilitation for this vulnerable population.</p><p><strong>Funding: </strong>Meagan Bebenek Foundation and University Health Network Foundation.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"78 ","pages":"102955"},"PeriodicalIF":9.6000,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11646794/pdf/","citationCount":"0","resultStr":"{\"title\":\"A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial.\",\"authors\":\"Mariana Misawa, Inci Yaman Bajin, Bill Zhang, Monica Daibert-Nido, Danielle Tchao, Eduardo Garcia-Giler, Kyle Cheung, Lora Appel, Pi Nasir, Arun Reginald, Uri Tabori, Ute Bartels, Vijay Ramaswamy, Samuel N Markowitz, Eric Bouffet, Michael Reber\",\"doi\":\"10.1016/j.eclinm.2024.102955\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Brain tumor in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and quality of life, yet no effective intervention exists for this pediatric population. This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to improve visual function and functional vision.</p><p><strong>Methods: </strong>In a phase 2a, open-labeled, nonrandomized, single-arm study, conducted from July 2022 to October 2023 (NCT05065268), 10 children and adolescents with stable hemianopia were enrolled to perform 20-min sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring adoption, adherence and completion rates, remote data transfer and qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were conducted pre- and post-intervention, with follow-ups at 1- and 6 months.</p><p><strong>Findings: </strong>The home-based 3D-MOT-IVR intervention proved both feasible and safe, with no reported adverse events. All participants completed the prescribed stimulations and the pre- and post-intervention assessment points, 90% completed the follow-ups. Nine out of ten participants showed clinically meaningful enhancement in visual function and/or functional vision, namely binocular visual field restoration and increased reading speed, but two showed concomitant deterioration in monocular visual field. These positive effects were sustained at the 6-month follow-up. Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual perception at the binocular visual field test.</p><p><strong>Interpretation: </strong>Our findings underscore the feasibility and safety of home-based audiovisual stimulation in immersive virtual-reality as a potential intervention for improving visual perception in children/adolescents with hemianopia consecutive to a pediatric brain tumor. These promising results lay a strong foundation for a larger randomized controlled trial, offering hope for a meaningful breakthrough in visual rehabilitation for this vulnerable population.</p><p><strong>Funding: </strong>Meagan Bebenek Foundation and University Health Network Foundation.</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"78 \",\"pages\":\"102955\"},\"PeriodicalIF\":9.6000,\"publicationDate\":\"2024-11-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11646794/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2024.102955\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2024.102955","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial.
Background: Brain tumor in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and quality of life, yet no effective intervention exists for this pediatric population. This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to improve visual function and functional vision.
Methods: In a phase 2a, open-labeled, nonrandomized, single-arm study, conducted from July 2022 to October 2023 (NCT05065268), 10 children and adolescents with stable hemianopia were enrolled to perform 20-min sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring adoption, adherence and completion rates, remote data transfer and qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were conducted pre- and post-intervention, with follow-ups at 1- and 6 months.
Findings: The home-based 3D-MOT-IVR intervention proved both feasible and safe, with no reported adverse events. All participants completed the prescribed stimulations and the pre- and post-intervention assessment points, 90% completed the follow-ups. Nine out of ten participants showed clinically meaningful enhancement in visual function and/or functional vision, namely binocular visual field restoration and increased reading speed, but two showed concomitant deterioration in monocular visual field. These positive effects were sustained at the 6-month follow-up. Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual perception at the binocular visual field test.
Interpretation: Our findings underscore the feasibility and safety of home-based audiovisual stimulation in immersive virtual-reality as a potential intervention for improving visual perception in children/adolescents with hemianopia consecutive to a pediatric brain tumor. These promising results lay a strong foundation for a larger randomized controlled trial, offering hope for a meaningful breakthrough in visual rehabilitation for this vulnerable population.
Funding: Meagan Bebenek Foundation and University Health Network Foundation.
期刊介绍:
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.