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Behavioural Intervention
Virtual Reality Rehabilitation for Hemianopia in Children (HH-IVR Trial)
N/A
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 8 years old
Be younger than 65 years old
Must not have
History of vertigo or dizziness
Prior vision rehabilitation interventions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 months
Awards & highlights
No Placebo-Only Group
Summary
This trial uses virtual reality headsets at home to help children aged 4-10 with vision loss from brain tumors. The program shows pictures and sounds together to help the brain improve vision in the affected areas. We have developed a novel application of adapted virtual reality (VR) technology to assist in vision improvement.
Who is the study for?
This trial is for children aged over 8 with hemianopia, a type of visual field loss, due to a brain tumor or its treatment. They must have decent vision (BCVA > 20/200), be able to follow instructions, and have home Wi-Fi. Kids with vertigo, previous vision rehab, certain eye diseases or drug use can't join.
What is being tested?
The study tests a home-based visual rehabilitation program using immersive virtual reality (IVR) designed for kids with hemianopia. It aims to see if this technology helps improve their ability to see and interact with the world around them.
What are the potential side effects?
Potential side effects may include discomfort from wearing VR equipment, eye strain from prolonged screen time, and possibly dizziness or disorientation related to VR use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are older than 8 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You have a history of feeling dizzy or lightheaded.
Select...
You have had previous treatments to improve your vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility and effectiveness of a home based audiovisual stimuaton in immersive virtual-reality to restore visual perception in children with brain tumour associated hemianopia.
Secondary study objectives
Change in Field of vision
Change in Quality of life
Change in Reading speed
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immersive Virtual-Reality Stimulation
2022
N/A
~10
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hemianopia, particularly those similar to Immerse-Virtual Reality (IVR) stimulation, work by stimulating visual pathways to promote neuroplasticity. IVR involves repetitive visual exercises that encourage the brain to adapt and reorganize itself, potentially restoring some visual field function.
This approach is crucial for Hemianopia patients as it leverages the brain's ability to rewire itself, thereby improving visual function and enhancing the patient's quality of life.
Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial.Low vision rehabilitation for better quality of life in visually impaired adults.Personality and stress influence vision restoration and recovery in glaucoma and optic neuropathy following alternating current stimulation: implications for personalized neuromodulation and rehabilitation.
Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial.Low vision rehabilitation for better quality of life in visually impaired adults.Personality and stress influence vision restoration and recovery in glaucoma and optic neuropathy following alternating current stimulation: implications for personalized neuromodulation and rehabilitation.
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,186 Total Patients Enrolled
University Health Network, TorontoOTHER
1,524 Previous Clinical Trials
503,194 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are older than 8 years.Your scores on the Vision Rehabilitation and Research In-Home Visual Functioning Evaluation have been consistently low.You have a history of feeling dizzy or lightheaded.You have had previous treatments to improve your vision.You have lost the ability to see on one side of both eyes.Your eye distance is more than 56 millimeters apart.Your eyesight with glasses or contacts is better than 20/200.You have access to Wi-Fi at home.You have eye diseases.Both of your eyes have cloudy areas that make it hard to do a certain eye test.You are unable to complete the required tests and training.Using drugs that affect the mind.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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