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

April 23, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks
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.
Other: Intervention
Visual stimulation for the first 8 weeks then standard of care for the following 8 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual field perimetry measured using the Esterman binocular field test
Time Frame: 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.
From enrollment to the end of follow up period at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Fight Kids Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25-57
  • ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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