Hemianopsia, Virtual Reality, Visual Rehabilitation, Pediatric Brain Tumor
Conditions
Keywords
brain tumor, pediatric, visual rehabilitation, virtual reality
Brief summary
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.
Interventions
DEVICEVisual Stimulation
Our 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.
OTHERstandard of care
During 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.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Fight Kids Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
We will perform a phase IIb, single blind (to assessor), prospective, randomized, controlled, multicentric, delayed-start, parallel-group study.
Eligibility
Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female * 10 - 40 years old * Diagnosed hemianopsia (\>12 months) * History of diagnosis brain tumour * Being stable for the tumour for \> 6 months (either on therapy or not) * Visual acuity ≤ 0.7 LogMAR * Ability to follow the visual and auditory stimuli and training instructions * Home WiFi access * Ability to attend all on site visits * Affiliation to the Social Security or beneficiary of such social protection
Exclusion criteria
* Age\< 10 years old of \> 40 years old * Ocular disease * Inability to perform during testing or training * 3 consecutive VRISE scores \< 25 at inclusion * History of vertigo * Prior vision rehabilitation interventions * Recreational or medicinal consumption of psychoactive drugs * Persons under court protection * Interpupillary distance \< 54mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual field perimetry measured using the Esterman binocular field test | From enrollment to the end of follow up period at 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant-reported a vision impairment specific quality of life questionnaire: Impact of Vision Impairment Questionnaire (IVI). | From enrollment to the end of follow up period at 6 months | 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 | From enrollment to the end of follow up period at 6 months | 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. |
Countries
Austria, Denmark, France, Italy, Netherlands, Spain, United Kingdom
Contacts
CONTACTMichael Reber, PhD
CONTACTNatacha Entz-Werle, Pr
Outcome results
None listed