ClinicalTrials.gg
Not yet recruitingNCT07558395REVIIH-BTUpdated Sep 16, 2026

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

An interventional study of Visual Stimulation and standard of care in Hemianopsia, Virtual Reality and Visual Rehabilitation, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Not yet recruiting at 8 sites in 7 countries. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemianopsia
  • Virtual Reality
  • Visual Rehabilitation
  • Pediatric Brain Tumor

Keywords

  • brain tumor
  • pediatric
  • visual rehabilitation
  • virtual reality
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's planned enrollment of 120 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Control

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

    Device: Visual Stimulation · Other: standard of care

  • Other
    Intervention

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

    Device: Visual Stimulation · Other: standard of care

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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

8 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.

Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's planned 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2025
First posted
Apr 30, 2026
StartEst.
Dec 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07558395
Collaborators
Fight Kids Cancer
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Michael Reber, PhD
Contact
michael.reber@inserm.fr
+33 388116648 ext. 17675
Natacha Entz-Werle, Pr
Contact
Natacha.Entz-Werle@chru-strasbourg.fr
0388128396

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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