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

Primary Purpose

Hemianopia, Brain Tumor, Children, Only

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Immersive Virtual-Reality Stimulation
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemianopia focused on measuring hemianopia, Brain tumor, children

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hospital for Sick Children
  • University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm 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).

Outcomes

Primary Outcome Measures

Feasibility
Feasibility objectives for our pilot study to be considered successful: . Number of patients completing the stimulation protocol: ≥ 8 out of 10 patients (80%). . Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 12 sessions out of 15 (80%). . Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: ≤ 3 per patient during the treatment period. . Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 2 (20%) during the treatment period.

Secondary Outcome Measures

Change in Visual acuity
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)
Change in Reading speed
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)
Change in Field of vision
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)
Change in Quality of life
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).

Full Information

First Posted
August 31, 2021
Last Updated
October 20, 2021
Sponsor
The Hospital for Sick Children
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05065268
Brief Title
Visual Rehabilitation in Children With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation
Acronym
HH-IVR
Official Title
Visual Rehabilitation in a Pediatric Population of Patients With Homonymous Hemianopia: a Pilot Study on Virtual-reality Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia, Brain Tumor, Children, Only
Keywords
hemianopia, Brain tumor, children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Immersive Virtual-Reality Stimulation
Intervention Description
IVR stimulation every 2 days (± 1 day) at any time during the day (delivery).
Primary Outcome Measure Information:
Title
Feasibility
Description
Feasibility objectives for our pilot study to be considered successful: . Number of patients completing the stimulation protocol: ≥ 8 out of 10 patients (80%). . Number of IVR sessions performed by the patients to consider the stimulation protocol complete: ≥ 12 sessions out of 15 (80%). . Number of consecutive virtual-reality induced symptoms and effects (VRISE) scores < 25: ≤ 3 per patient during the treatment period. . Number of patient drop-outs due to cybersickness (discomfort symptoms experienced in VR): ≤ 2 (20%) during the treatment period.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Change in Visual acuity
Description
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)
Time Frame
7 months
Title
Change in Reading speed
Description
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)
Time Frame
4 weeks
Title
Change in Field of vision
Description
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)
Time Frame
4 weeks
Title
Change in Quality of life
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Homonymous hemianopsia Male and female. > 8 years old Interpupillary distance >=56 mm BCVA > 20/200 Ability to follow visual and auditory stimuli and training instructions. Home Wi-Fi access. Exclusion Criteria: Ocular diseases Both eyes with media opacity that impairs microperimetry testing. Inability to perform during testing and training. Consumption of psychoactive drugs. 3 consecutive VRISE scores < 25 at inclusion. History of vertigo or dizziness Prior vision rehabilitation interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Bouffet, MD
Phone
4168134670
Email
eric.bouffet@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Reber, MD
Phone
416-634-7937
Email
michel.reber@uhnresearch.ca
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Fonseca, MD
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Bouffet, MD
Phone
4168134678
Email
eric.bouffet@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Michael Reber, MD
Phone
416-634-7937
Email
michel.reber@uhnresearch.ca

12. IPD Sharing Statement

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

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