Audiovisual Stimulation for Hemianopia from Brain Tumors

(HHREHAB Trial)

Recruiting at 4 trial locations

Overseen By Eric Bouffet, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Psychoactive drugs

Disqualifiers: Ocular disease, Vertigo, Prior rehab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not consume recreational or medicinal psychoactive drugs.

What data supports the effectiveness of the treatment Re:Vision for hemianopia from brain tumors?

Research shows that audiovisual stimulation, similar to the Re:Vision treatment, can improve visual perception and quality of life in hemianopia patients. Studies using virtual-reality devices for home-based rehabilitation have demonstrated increased contrast sensitivity and improved visual fields, suggesting potential effectiveness for Re:Vision. ^{1 2 3 4 5}

How does the Re:Vision treatment for hemianopia from brain tumors differ from other treatments?

Re:Vision is unique because it uses a virtual-reality headset for audiovisual stimulation, allowing patients to do the treatment at home rather than in a clinic. This approach is novel as it combines visual and auditory cues to improve vision in the blind areas, potentially activating multisensory neurons in the brain, and it has shown promising results in improving visual perception and quality of life. ^{1 2 3 4 6}

Research Team

Eric Bouffet, MD

Principal Investigator

Hospital of Sick Children

Michael Reber, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals aged 10-40 who have hemianopia due to a pediatric brain tumor. Participants will engage in an at-home visual rehabilitation program using virtual reality, and must be able to perform the exercises independently with remote supervision.

Inclusion Criteria

I am either male or female.

I have been diagnosed with partial blindness for over 18 months.

I can follow visual and auditory instructions.

Exclusion Criteria

I am over 40 years old.

I cannot perform tasks during tests and training.

3 consecutive VRISE (cybersickness) scores below 25 at inclusion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 hours

1 visit (in-person)

Treatment

Participants undergo an 8-week audiovisual stimulation program using immersive virtual reality at home

8 weeks

28 sessions (home-based)

Observation

Participants are observed without intervention to assess the sustainability of the treatment effects

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• Re:Vision

Trial Overview The study tests 'Re:Vision', an 8-week home-based visual telerehabilitation program using audiovisual stimulation in a VR environment. It aims to improve visual perception in those affected by vision loss from brain tumors.

Participant Groups

Group I: Intervention - No Intervention Experimental Treatment 1 Intervention

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

Group II: No Intervention - Intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Alberta Children's Hospital

Collaborator

Trials

58

Recruited

44,700+

British Columbia Children's Hospital

Collaborator

Trials

27

Recruited

15,600+

St. Justine's Hospital

Collaborator

Trials

205

Recruited

87,300+

Findings from Research

A 4-week virtual-reality audiovisual rehabilitation program significantly improved visual perception, contrast sensitivity, and fixation stability in a 15-year-old patient with right homonymous hemianopia, enhancing his quality of life.

This study demonstrates that remote-controlled virtual-reality therapy can effectively provide low-vision rehabilitation at home, challenging the notion that vision loss after injury is permanent and unchangeable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. Daibert-Nido, M., Pyatova, Y., Cheung, KG., et al.[2021]

A home-based virtual-reality visual rehabilitation program was feasible for two patients with hemianopia due to pediatric brain tumors, with both completing nearly all scheduled sessions (19/20 and 20/20).

The program showed potential effectiveness, as both patients experienced improvements in contrast sensitivity, visual fields, reading speed, and quality of life, particularly notable in case 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. Daibert-Nido, M., Pyatova, Y., Cheung, K., et al.[2021]

A novel approach using passive auditory stimulation significantly improved visual detection in patients with hemianopia, showing nearly a 100% increase in performance shortly after stimulation on the blind side.

The improvement in visual detection was temporary, lasting about 1.5 hours, suggesting that auditory stimulation may activate residual visual pathways, highlighting a potential new method for rehabilitation of visual field disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive auditory stimulation improves vision in hemianopia. Lewald, J., Tegenthoff, M., Peters, S., et al.[2021]

A new rehabilitation approach using audio-visual stimulation showed promising results in improving visual field defects in 8 patients, with training sessions lasting 4 hours daily over nearly 2 weeks.

Patients demonstrated significant improvements in visual detection and oculomotor exploration, which translated to better performance in daily activities, with benefits lasting up to one month after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual search improvement in hemianopic patients after audio-visual stimulation. Bolognini, N., Rasi, F., Coccia, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Passive auditory stimulation improves vision in hemianopia. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Audio-visual stimulation for visual compensatory functions in stroke survivors with visual field defect: a systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Visual search improvement in hemianopic patients after audio-visual stimulation. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Audio-Visual Stimulation Improves Visual Search Abilities in Hemianopia due to Childhood Acquired Brain Lesions. [2019]