What side effects are associated with this type of intervention?

Common side effects of treatments for hemianopia, particularly those involving virtual reality and visual stimulation like the IVR approach, include motion sickness, dizziness, eye strain, and headaches. These side effects are typically mild and temporary. Broader treatments such as visual field training may cause frustration or fatigue due to their repetitive nature.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for hemianopia that involve stimulation of visual pathways similar to the Immerse-Virtual Reality (IVR) being studied. Hemianopia, often resulting from brain tumors or their treatment, lacks targeted visual rehabilitation strategies. The IVR approach is a novel area of research aimed at improving visual field defects in children through home-based stimulation programs.

What other types of research exist?

Promising novel alternatives to IVR for hemianopia patients include: 1) Neuroplasticity-based therapies, which leverage the brain's ability to reorganize and form new neural connections. 2) Non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which can enhance visual processing and recovery. 3) Pharmacological interventions targeting neural repair and regeneration. 4) Advanced visual prosthetics and augmented reality (AR) devices that provide real-time visual field expansion and enhancement.

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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

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 below

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You are older than 8 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a history of feeling dizzy or lightheaded.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

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 more

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

0 / 3Eligibility criteria met

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.

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