Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour

NCT06362434 | Not Yet Recruiting

• 1 other identifier: UHN-HHREHAB-24-xxxx
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor. Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life. Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada. This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies.

Conditions

Hemianopsia

Keywords

pediatric brain tumor; visual fields; quality of life; reading; MRI; SD-OCT

Outcome Measures

Primary Outcomes (1)

• Binocular Visual Field

  Difference in the number of points perceived in the Esterman binocular field test between intervention and non-intervention groups and pre/post-intervention

  From enrollment to the end of the study at 6 months

Secondary Outcomes (5)

• Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25

  From enrollment to the end of the study at 6 months

• Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF

  From enrollment to the end of the study at 6 months

• Reading Speed

  From enrollment to the end of the study at 6 months

• Fixation Stability

  From enrollment to the end of the study at 6 months

• Contrast Sensitivity

  From enrollment to the end of the study at 6 months

Other Outcomes (6)

• Brain Activity - Visually-evoked potentials

  From enrollment to the end of the study at 6 months

• Retinal Integrity

  From enrollment to the end of the study at 6 months

• Brain imaging - Tractography

  From enrollment to the end of the study at 6 months

Study Arms (2)

Intervention - No Intervention

EXPERIMENTAL

8-week audiovisual stimulation followed by 8-week no intervention

Device: Audiovisual stimulation

No Intervention - Intervention

NO INTERVENTION

8-week no intervention followed by 8-week audiovisual stimulation

Interventions

Audiovisual stimulation DEVICE

The MOT IVR audiovisual stimulation task involves the 3D multiple-object-tracking paradigm composed of 6-8 high-contrast spheres which features are adapted to the visual ability of individuals with low-vision (luminosity = 80 nits, size = 1° to 3° visual angle). The spheres move for 20s. following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. The participant, comfortably seated, is asked to track the moving cued target among moving distractors for 20s. A spatial sound is correlated to the movement of the cued target. After 20s., the movement stops and the participant is asked to select, using a laser pointer, the cued sphere among the distractors (mark-all procedure). Speed of the spheres is regulated by a staircase 1:1 procedure. The stimulation can here be stopped by the participant if required. After 3 blocks of 15x20s., the system stops and goes on stand-by mode until the next session. Data are collected in real time.

Intervention - No Intervention

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed hemianopsia (\> 18 months).
• History of a diagnosis of brain tumour
• Being stable for the tumour for \>18 months (either on therapy or not)
• Male and female
• years old
• Ability to follow the visual and auditory stimuli and training instructions.
• Online auditory test positive (-5dbHL to 60dbHL range) at 125 Hz (for research purposes only)
• Home Wi-Fi access.

You may not qualify if:

• \< 10 years old.
• \> 40 years old.
• Ocular disease
• Both eyes with media opacity that impairs microperimetry testing.
• Inability to perform during testing and training.
• Recreational or medicinal consumption of psychoactive drugs.
• History of vertigo or dizziness.
• Prior vision rehabilitation interventions.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Alberta Children's Hospital: collaborator
• St. Justine's Hospital: collaborator
• The Hospital for Sick Children: collaborator
• British Columbia Children's Hospital: collaborator

Study Sites (5)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Québec

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Reber, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Eric Bouffet, MD

  Hospital of Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Reber, PhD

CONTACT

416-634-7937; michael.reber@uhn.ca

Eric Bouffet, MD

CONTACT

416-834-7937; eric.bouffet@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CA (5)