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

NCT07558395 | Not Yet Recruiting

• 2 other identifiers: C25-57ID-RCB
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 8

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.

Conditions

Pediatric Brain Tumor; Hemianopsia; Visual Rehabilitation; Virtual Reality

Keywords

brain tumor; pediatric; visual rehabilitation; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• Reading speed - Minnesota Low Vision Reading (MNREAD) test

  From enrollment to the end of follow up period at 6 months

Study Arms (2)

Control

OTHER

Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks

Device: Visual Stimulation; Other: standard of care

Intervention

OTHER

Visual stimulation for the first 8 weeks then standard of care for the following 8 weeks

Device: Visual Stimulation; Other: standard of care

Interventions

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.

Control; Intervention

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.

Control; Intervention

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and Female
• 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

You may not qualify if:

• Age\< 10 years old of \> 40 years old
• Ocular disease
• Inability to perform during testing or training
• History of vertigo
• Prior vision rehabilitation interventions
• Recreational or medicinal consumption of psychoactive drugs
• Persons under court protection
• Interpupillary distance \< 54mm

Sponsors & Collaborators

• Fight Kids Cancer: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (8)

Department of Paediatric and adolescents medicine, Medical University

Vienna, Austria

Location

Paediatrics and Adolescents Medicine, University Hospital

Copenhagen, Denmark

Location

Hôpital de Hautepierre

Strasbourg, France

Location

Institute of Tumour, department of haematology and Oncohaematology paediatric

Milan, Italy

Location

Paediatric Haematology, University Hospital

Padova, Italy

Location

Princess Maxima Centre for Paediatric Oncology

Utrecht, Netherlands

Location

Paediatric Oncology, San Joan de Deu

Barcelona, Spain

Location

Great Ormond Street Hospital for Children

London, United Kingdom

Location

MeSH Terms

Conditions

Hemianopsia; Brain Neoplasms

Interventions

Photic Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Michael Reber, PhD

CONTACT

+33 388116648; michael.reber@inserm.fr

Natacha Entz-Werle, Pr

CONTACT

0388128396; Natacha.Entz-Werle@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: We will perform a phase IIb, single blind (to assessor), prospective, randomized, controlled, multicentric, delayed-start, parallel-group study.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: April 30, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

IT (2); NL (1); ES (1); GB (1); AU (1); DK (1); FR (1)