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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2025-A02007-42 |
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| Name | Class |
|---|---|
| Fight Kids Cancer | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks |
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| Intervention | Other | Visual stimulation for the first 8 weeks then standard of care for the following 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of follow up period at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Reber, PhD | Contact | +33 388116648 | 17675 | michael.reber@inserm.fr |
| Natacha Entz-Werle, Pr | Contact | 0388128396 | Natacha.Entz-Werle@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatric and adolescents medicine, Medical University | Vienna | Austria |
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We will perform a phase IIb, single blind (to assessor), prospective, randomized, controlled, multicentric, delayed-start, parallel-group study.
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| standard of care | Other | 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. |
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| From enrollment to the end of follow up period at 6 months |
| 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. | From enrollment to the end of follow up period at 6 months |
| Paediatrics and Adolescents Medicine, University Hospital | Copenhagen | Denmark |
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| Hôpital de Hautepierre | Strasbourg | France |
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| Institute of Tumour, department of haematology and Oncohaematology paediatric | Milan | Italy |
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| Paediatric Haematology, University Hospital | Padova | Italy |
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| Princess Maxima Centre for Paediatric Oncology | Utrecht | Netherlands |
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| Paediatric Oncology, San Joan de Deu | Barcelona | Spain |
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| Great Ormond Street Hospital for Children | London | United Kingdom |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001766 | Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010775 | Photic Stimulation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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