A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumour: a single-arm feasibility and proof-of-concept trial.

Background. Brain tumour in children can induce hemianopia, a loss of conscious vision, profoundly impacting their development and future prospects, yet no effective intervention exists for this pediatric population. This study aims to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT-IVR) to restore visual perception. Method. In a phase 2a, open-labeled, nonrandomized, single arm study, 10 children and adolescents with stable hemianopia were enrolled to perform 20-minute sessions of 3D-MOT-IVR every other day for six weeks from home. We assessed feasibility by monitoring completion rates, remote data transfer, qualitative feedback. Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments were conducted pre- and post-intervention, with follow-ups at 1- and 6-month intervals. Results. 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. Remarkably, the outcomes revealed significant improvements post-intervention: 50% of participants showed enhanced visual perception in their blind field, while 70% exhibited increased reading speed. Importantly, these positive effects were sustained at the 6-month follow-up. A robust correlation emerged between 3D-MOT-IVR performance and improved visual perception in the blind field, emphasizing the intervention's effectiveness. Conclusion. Our findings underscore the feasibility and safety of home-based 3D-MOT-IVR as a potential intervention for hemianopia in children. 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05065268 ### Funding Statement This study was funded by Meagan Bebenek Foundation and University Health Network Foundation. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study protocol was approved by the Research Ethics Boards at the Hospital for Sick Children in Toronto, Canada (Sickkids REB# 1000076413) and at University Health Network, Toronto, Canada (UHN REB# 21-5978) and registered on clinicaltrials.gov ([NCT05065268][1]) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05065268&atom=%2Fmedrxiv%2Fearly%2F2024%2F01%2F26%2F2024.01.25.24301666.atom