About this trial
Evaluate the efficiency of audiovisual stimulation in virtual reality for improving the visual perception of children, adolescents, and young adults with hemianopia resulting from pediatric brain tumors. These individuals can lose up to 50% of their visual field, significantly impacting their independence, mobility, and daily lives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and Female
10 - 40 years old
Diagnosed hemianopsia (>12 months)
History of diagnosis brain tumour
Disqualifiers
Age< 10 years old of > 40 years old
Ocular disease
Inability to perform during testing or training
3 consecutive VRISE scores < 25 at inclusion
Trial design
Parallel
Treatments tested in this trial
Visual Stimulation
DeviceOur audiovisual stimulation procedure IVR, called 3D-MOT, was encoded using the the 3D Unity programming platform and deployed in HMDs with built-in head/eye tracking. We implemented the multiple object tracking (MOT) paradigm, developed in the 80's to study visual attention in humans, and added correlated spatial sound.
standard of care
Other interventionDuring this phase, the patients will be at home without a headset and will not be exposed to an audio-visual stimulation task in virtual reality.
Treatment groups
Trial outcomes
Primary outcomes
Visual field perimetry measured using the Esterman binocular field test
Increase at least 3 points in the number of points perceived in the blind field at the Esterman binocular field test after intervention (8 weeks) when compared to baseline and between control and interventional group.
Secondary outcomes
Participant-reported a vision impairment specific quality of life questionnaire: Impact of Vision Impairment Questionnaire (IVI).
Questionnaire will be provided and compared at baseline and after intervention ( 8 weeks) and between control and interventional group. A diminution of the mean score above 0.3-0.5 point will be consider as an amelioration of quality of life impacted by vision impairment.
Reading speed - Minnesota Low Vision Reading (MNREAD) test
Reading speed will be assessed and compared at baseline and after intervention (8 weeks) and between control and interventional groups. An increase in reading speed of 8.6 words per minute on the Minnesota Low Vision Reading (MNREAD) test will be considered an improvement in the variable.
Sponsors and contacts
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Institut National de la Santé Et de la Recherche Médicale, France
Lead sponsor
Fight Kids Cancer
Collaborator
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