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Clinical Trials in Canada / NCT06362434
Starting soon Not applicable

Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour

NCT06362434 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2024-06-01
Last updated
2024-04-12

Condition(s) studied

Hemianopsia

Investigational drug(s) / intervention(s)

Audiovisual stimulation

Audiovisual stimulation: The MOT IVR audiovisual stimulation task involves the 3D multiple-object-tracking paradigm composed of 6-8 high-contrast spheres which features are adapted to the visual ability of individuals with low-vision (luminosity = 80 nits, size = 1° to 3° visual angle). The spheres move for 20s. following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. The participant, comfortably seated, is asked to track the moving cued target among moving distractors for 20s. A spatial sound is correlated to the movement of the cued target. After 20s., the movement stops and the participant is asked to select, using a laser pointer, the cued sphere among the distractors (mark-all procedure). Speed of the spheres is regulated by a staircase 1:1 procedure. The stimulation can here be stopped by the participant if required. After 3 blocks of 15x20s., the system stops and goes on stand-by mode until the next session. Data are collected in real time.

Study summary

Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor.

Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life.

Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada.

This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies.

Eligibility

Sex
ALL
Min age
10 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosed hemianopsia (\> 18 months). * History of a diagnosis of brain tumour * Being stable for the tumour for \>18 months (either on therapy or not) * Male and female * 10 - 40 years old * Ability to follow the visual and auditory stimuli and training instructions. * Online auditory test positive (-5dbHL to 60dbHL range) at 125 Hz (for research purposes only) * Home Wi-Fi access. Exclusion Criteria: * \< 10 years old. * \> 40 years old. * Ocular disease * Both eyes with media opacity that impairs microperimetry testing. * Inability to perform during testing and training. * Recreational or medicinal consumption of psychoactive drugs. * 3 consecutive VRISE (cybersickness) scores \< 25 at inclusion. * History of vertigo or dizziness. * Prior vision rehabilitation interventions.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Alberta Children's Hospital Calgary Alberta
British Columbia Children's Hospital Vancouver British Columbia
The Hospital for Sick Children Toronto Ontario
Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
CHU de Québec Québec Quebec

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06362434 on ClinicalTrials.gov ↗ ← All trials in Canada