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

ConditionHemianopsia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-40
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

< 10 years old.

> 40 years old.

Ocular disease

Both eyes with media opacity that impairs microperimetry testing.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Audiovisual stimulation

    Device

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intervention - No InterventionExperimental treatment 1 intervention
Group B: No Intervention - InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Binocular Visual Field

Difference in the number of points perceived in the Esterman binocular field test between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months

Secondary outcomes

1

Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25

Difference in quality of vision questionnaire scores between intervention and non-intervention groups and pre/post-intervention. Scores are from 0 to 100. High scores represents better outcome.

Time frame
From enrollment to the end of the study at 6 months
2

Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF

Difference in quality of vision questionnaire scores between intervention and non-intervention groups and pre/post-intervention. Scores are from 0 to 100. High scores represents better outcome.

Time frame
From enrollment to the end of the study at 6 months
3

Reading Speed

Difference in the number of words per minute (at critical print size) between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months
4

Fixation Stability

Difference in fixation stability (BCEA 63%, degree square) between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months

Other outcomes

1

Brain Activity - Visually-evoked potentials

Difference in brain activity (VEP EEG) between intervention and non-intervention groups and pre/post-intervention. Measures of N75, P100 and N175 latency (ms) and amplitude (microV) during monocular pattern reversal stimulation.

Time frame
From enrollment to the end of the study at 6 months
2

Retinal Integrity

Difference in retinal fiber layer thickness (RNFL) between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months
3

Brain imaging - Tractography

Measures of optic tract density will be performed by diffusion tensor MRI (DTI - fractional anisotropy, tractography) between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months
4

Brain imaging - Retinotopy

Retinotopic visual stimulation will be performed by visual stimulation at 4 different retinal positions and measured using population receptive field (voxels value) between intervention and non-intervention groups and pre/post-intervention

Time frame
From enrollment to the end of the study at 6 months

Sponsors and contacts

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University Health Network, Toronto

Lead sponsor

Alberta Children's Hospital

Collaborator

St. Justine's Hospital

Collaborator

The Hospital for Sick Children

Collaborator

British Columbia Children's Hospital

Collaborator

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