Clinical trial · Interventional
Visual Rehabilitation in Children With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation
Visual Rehabilitation in a Pediatric Population of Patients With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation
NCT05065268CI-TRIAL-00073449HH-IVRcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are currently no visual rehabilitation strategies for children presenting visual field defects consecutive to a brain tumor or its treatment. This study seeks to investigate the use of a home-based stimulation visual rehabilitation program using immerse-virtual reality (IVR) in children aged 4-10 years old with a diagnosis of hemianopia
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Children, Only | — | UNRESOLVED | — |
| Hemianopia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immersive Virtual-Reality Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Immersive virtual-reality stimulation (IVR): 1 session of 3 blocks of 15 trials of 20 seconds each. Rest time is 1-2 minute(s) between blocks. 1 session lasts 19 minutes.1 session every 2 days for 4 weeks (15 sessions total).
- interventionNames
- Device: Immersive Virtual-Reality Stimulation
Primary outcomes (1)
- measure
- Feasibility and effectiveness of a home based audiovisual stimuaton in immersive virtual-reality to restore visual perception in children with brain tumour associated hemianopia.
- timeFrame
- 7 months
- description
- Feasibility objectives for our pilot study to be considered successful 1. . Number of patients completing the stimulation protocol: ≥ 8 out of 10 patients (80%). 2. . Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 12 sessions out of 15 (80%). 3. . Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores \< 25: ≤ 3 per patient during the treatment period. 4. . Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 2 (20%) during the treatment period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Homonymous hemianopsia 2. Male and female. 3. \> 8 years old 4. Interpupillary distance \>=56 mm 5. BCVA \> 20/200 6. Ability to follow visual and auditory stimuli and training instructions. 7. Home Wi-Fi access. Exclusion Criteria: 1. Ocular diseases 2. Both eyes with media opacity that impairs microperimetry testing. 3. Inability to perform during testing and training. 4. Consumption of psychoactive drugs. 5. 3 consecutive VRISE scores \< 25 at inclusion. 6. History of vertigo or dizziness 7. Prior vision rehabilitation interventions.
References
Publications (0)
Data not yet available
No reference posted for this study.