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Not yet recruiting NCT07558395

Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour

No phase Interventional Hemianopsia Virtual Reality Visual Rehabilitation Pediatric Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual Stimulation, standard of care.
Who it may be relevant to
Registry conditions: Hemianopsia, Virtual Reality, Visual Rehabilitation, Pediatric Brain Tumor. Basic parameters: 10 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Denmark, France, Italy, Netherlands +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Visual 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.
  • Other standard 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.

Primary outcome measures

  • Visual field perimetry measured using the Esterman binocular field test [Time frame: From enrollment to the end of follow up period at 6 months]
Secondary outcome measures (2)
  • Participant-reported a vision impairment specific quality of life questionnaire: Impact of Vision Impairment Questionnaire (IVI). [Time frame: From enrollment to the end of follow up period at 6 months]
  • Reading speed - Minnesota Low Vision Reading (MNREAD) test [Time frame: From enrollment to the end of follow up period at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Italy · 2 centers
  • Institute of Tumour, department of haematology and Oncohaematology paediatric — Milan
  • Paediatric Haematology, University Hospital — Padova
Austria · 1 center
  • Department of Paediatric and adolescents medicine, Medical University — Vienna
Denmark · 1 center
  • Paediatrics and Adolescents Medicine, University Hospital — Copenhagen
France · 1 center
  • Hôpital de Hautepierre — Strasbourg
Netherlands · 1 center
  • Princess Maxima Centre for Paediatric Oncology — Utrecht
Spain · 1 center
  • Paediatric Oncology, San Joan de Deu — Barcelona
United Kingdom · 1 center
  • Great Ormond Street Hospital for Children — London

Identifiers

NCT: NCT07558395 · C25-57 · ID-RCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗