NCT05065268

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

August 31, 2021

Last Update Submit

January 29, 2024

Conditions

HemianopiaBrain TumorChildren, Only

Keywords

hemianopiaBrain tumorchildren

Outcome Measures

Primary Outcomes (1)

  • Feasibility and effectiveness of a home based audiovisual stimuaton in immersive virtual-reality to restore visual perception in children with brain tumour associated hemianopia.

    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.

    7 months

Secondary Outcomes (4)

  • Change in Visual acuity

    7 months

  • Change in Reading speed

    4 weeks

  • Change in Field of vision

    4 weeks

  • Change in Quality of life

    4 weeks

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

Immersive Virtual-Reality StimulationDEVICE

IVR stimulation every 2 days (± 1 day) at any time during the day (delivery).

Interventional

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Ocular diseases
  • Both eyes with media opacity that impairs microperimetry testing.
  • Inability to perform during testing and training.
  • Consumption of psychoactive drugs.
  • History of vertigo or dizziness
  • Prior vision rehabilitation interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

University Health Network

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

HemianopsiaBrain Neoplasms

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Visual rehabilitation using home based audiovisual rehabilitation in immersive virtual reality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Neuro-oncology

Study Record Dates

First Submitted

August 31, 2021

First Posted

October 4, 2021

Study Start

March 1, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

CA(2)