HemianopsiaREVIIH-BTNCT07558395
Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
A study testing Visual Stimulation in people with Hemianopsia and Virtual Reality, run by Institut National de la Santé Et de la Recherche Médicale, France at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Hemianopsia, Virtual Reality, Visual Rehabilitation
- What is being tested?
- Visual Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Dec 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- Recreational or medicinal consumption of psychoactive drugs
- Persons under court protection
- Interpupillary distance < 54mm
Trial locations and contacts
8 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 7 countries
Italy2 sites
Institute of Tumour, department of haematology and Oncohaematology paediatric
Milan
Elisabetta Schiavello, Dr, 390223902588, elisabetta.schiavello@istitutotumori.mi.it
Paediatric Haematology, University Hospital
Padova
enrico Opocher, Dr, 390498211493, enrico.opocher@aopd.veneto.it
Austria1 site
Department of Paediatric and adolescents medicine, Medical University
Vienna
Amadeo Azizi, Pr, 4314040032320, amedeo.azizi@meduniwien.at
Denmark1 site
Paediatrics and Adolescents Medicine, University Hospital
Copenhagen
Astrid Sehested, Pr, 04535451367, astrid.marie.sehested@regionh.dk
France1 site
Hôpital de Hautepierre
Strasbourg
Natacha Entz-Werle, Pr, 0388128396, Natacha.Entz-Werle@chru-strasbourg.fr
Netherlands1 site
Princess Maxima Centre for Paediatric Oncology
Utrecht
Lisethe Meijer, Dr, 00 31 6 5000 6503, l.meijer-13@prinsesmaximacentrum.nl
Spain1 site
Paediatric Oncology, San Joan de Deu
Barcelona
Miriam Pavon, Dr, 34610570117, miriam.pavon@sjd.es
United Kingdom1 site
Great Ormond Street Hospital for Children
London
Darren Pr Hargrave, 0442078298832, d.hargrave@ucl.ac.uk
About this study
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.
- Being tested
- Visual Stimulation, standard of care
- Keywords
- brain tumor, pediatric, visual rehabilitation, virtual reality
- Medical subject headings
- Hemianopsia, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual StimulationDevice
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.
standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard of care for the first 8 weeks then visual stimulation for the following 8 weeks Receives: 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 Receives: Device: Visual Stimulation; Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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.
Measured: From enrollment to the end of follow up period at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopsiaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will perform a phase IIb, single blind (to assessor), prospective, randomized, controlled, multicentric, delayed-start, parallel-group study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Fight Kids Cancer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558395
- Sponsor's protocol ID
- C25-57
- Other IDs
- ID-RCB
- Acronym
- REVIIH-BT
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
- ClinicalTrials.gov ID
- NCT07558395
- Acronym / sponsor ID
- REVIIH-BT / C25-57
- Keywords
- brain tumor, pediatric, visual rehabilitation, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Fight Kids Cancer
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will perform a phase IIb, single blind (to assessor), prospective, randomized, controlled, multicentric, delayed-start, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: Visual Stimulation, Other: standard of careStandard of care for the first 8 weeks then visual stimulation for the following 8 weeks |
| Intervention | Other | Device: Visual Stimulation, Other: standard of careVisual stimulation for the first 8 weeks then standard of care for the following 8 weeks |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual StimulationOur 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. | Device | Control, Intervention |
| standard of careDuring 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 | Control, Intervention |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Stimulation in people with Hemianopsia and Virtual Reality, run by Institut National de la Santé Et de la Recherche Médicale, France at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Austria, Denmark, France, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Reber, PhD (+33 388116648 ext. 17675, michael.reber@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field perimetry measured using the Esterman binocular field test (time frame: From enrollment to the end of follow up period at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.