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Visual Rehabilitation in Children With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation (HH-IVR)

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ClinicalTrials.gov Identifier: NCT05065268
Recruitment Status : Not yet recruiting
First Posted : October 4, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Eric Bouffet, The Hospital for Sick Children

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hemianopia Brain Tumor Children, Only Device: Immersive Virtual-Reality Stimulation Not Applicable

Detailed Description:

A brain tumor and its treatment can affect the visual system at different levels, from the optic nerves (through compression or infiltration). Children with brain tumors can present visual impairments like decreased visual acuity and contrast sensitivity, loss of color vision, and visual field loss such as hemianopias. Patients with hemianopia present difficulties in detecting stimuli in the defective visual field and show defective scanning and exploration. Moreover, they show a rotation and compression of the auditory space leading to imprecise localization of sound across both hemispaces. Patients with hemianopia naturally develop oculomotor strategies to compensate for visual field loss, but visual rehabilitation procedures must still be developed to optimize/improve visual perception in the blind field. Several studies demonstrated that these patients could improve visual perception in the damaged hemifield after a stimulation procedure where auditory and visual stimuli were temporally and spatially correlated. Such audiovisual stimulation programs induce a functional and anatomical reorganization of the visual connectivity in subcortical and cortical structures over time.

The current strategies rely on a significant workload, over 30 hours of audiovisual stimulation using static, spatially, and temporally coherent stimuli displayed on large screens/panels in a clinical setting. These strategies require frequent visits to the clinic impeding the patients' adherence and compliance and increasing the burden of disease. We seek to develop an audiovisual stimulation procedure using immersive virtual reality (IVR) using a head-mounted display (HMD). This is an emerging and very promising visual rehabilitation approach using high-technology devices. It is developed to provide sensory stimulation with better ecological validity due to virtual reality, greater flexibility due to home-based programs, and improved efficiency due to patient-tailored protocols. IVR is a versatile technology, allowing its potential use for the rehabilitation of a variety of low-vision conditions. There are currently limited practical results on whether this technology is suitable for low-vision patients to use at home and if it can be deployed on a large scale. A few case reports/series studies suggested the potential effectiveness of IVR on visual perception in teenagers, adults, and the elderly but more information as to the potential of use and effectiveness of this technology in children and young teenagers is necessary

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Visual Rehabilitation in a Pediatric Population of Patients With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Interventional
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).
Device: Immersive Virtual-Reality Stimulation
IVR stimulation every 2 days (± 1 day) at any time during the day (delivery).




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 7 months ]

    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.


Secondary Outcome Measures :
  1. Change in Visual acuity [ Time Frame: 7 months ]

    Corresponds to the potential effectiveness of IVR stimulation in visual acuity assessed by standard procedures by ophthalmologists.

    -Best Corrected Visual Acuity, distance, and near vision (range 20/12.5 to <20/1000, higher score = better outcome)


  2. Change in Reading speed [ Time Frame: 4 weeks ]

    This corresponds to the potential effectiveness of IVR stimulation in reading speed assessed by standard procedures by ophthalmologists.

    Endpoints will measure change from baseline at 2 and 4 weeks in:

    -Mean reading speed (Minnesota Low Vision Reading test, MNREAD - range 0 words/minute to 280 words/minute, higher score = better outcome)


  3. Change in Field of vision [ Time Frame: 4 weeks ]

    This corresponds to the potential effectiveness of IVR stimulation in the field of vision assessed by standard procedures by ophthalmologists.

    Endpoints will measure change from baseline at 2 and 4 weeks in:

    -Mean contrast sensitivity (Functional Acuity Contrast Test, FACT - range 0.48 cyc./deg. to 2.41 cyc./deg., higher score = better outcome)


  4. Change in Quality of life [ Time Frame: 4 weeks ]

    This corresponds to the potential effectiveness of IVR stimulation in the quality of life.

    Endpoints will measure change from baseline at 2 and 4 weeks in:

    -Quality of life scores (Children's Vision Function Questionnaire, higher score = better outcome).




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05065268


Contacts
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Contact: Eric Bouffet, MD 4168134670 eric.bouffet@sickkids.ca
Contact: Michael Reber, MD 416-634-7937 michel.reber@uhnresearch.ca

Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Contact: Adriana Fonseca, MD         
University Health Network
Toronto, Ontario, Canada, M5G1X8
Contact: Eric Bouffet, MD    4168134678    eric.bouffet@sickkids.ca   
Contact: Michael Reber, MD    416-634-7937    michel.reber@uhnresearch.ca   
Sponsors and Collaborators
The Hospital for Sick Children
University Health Network, Toronto
  Study Documents (Full-Text)

Documents provided by Eric Bouffet, The Hospital for Sick Children:
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Responsible Party: Eric Bouffet, Head of Pediatric Neuro-oncology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT05065268    
Other Study ID Numbers: 1000076413
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Bouffet, The Hospital for Sick Children:
hemianopia
Brain tumor
children
Additional relevant MeSH terms:
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Brain Neoplasms
Hemianopsia
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Blindness
Eye Diseases