Audiovisual Stimulation for Hemianopia from Brain Tumors

(HHREHAB Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Re:Vision, which uses virtual reality with audio and visual exercises to assist people with hemianopia (loss of vision in half of the visual field) due to brain tumors. The goal is to determine if this 8-week home-based program can improve vision and quality of life for participants. The trial includes two groups: one starts with the program, and the other begins without it, then both switch. Individuals who have had hemianopia for over 18 months and a history of brain tumors might be suitable candidates, especially if they have home Wi-Fi access.

As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance daily living.

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 prior data suggests that this audiovisual stimulation is safe for individuals with hemianopia?

Research has shown that the Re:Vision program, which uses virtual reality to enhance vision, is generally safe for users. In earlier studies, patients used a virtual reality system at home to work on their vision. These studies found the program to be both practical and safe. Participants did not report any major negative side effects during use. This suggests that the treatment is well-tolerated and could be a safe option for people with vision problems due to brain tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Re:Vision for hemianopia caused by brain tumors because it offers a non-invasive approach that uses audiovisual stimulation to potentially restore vision. Unlike traditional therapies that often rely on medication or surgery, Re:Vision targets visual processing pathways in the brain directly. This innovative method could provide a safer and more comfortable alternative for patients, with the potential for fewer side effects and the ability to be used at home.

What evidence suggests that this audiovisual stimulation is effective for hemianopia?

Research has shown that the Re:Vision program, which participants in this trial may receive, may help children who have lost half of their vision due to brain tumors. Early results from young patients suggest that their vision and perception can improve after a 6-week program. Specifically, one study found a strong positive connection between the 3D-MOT-IVR treatment and better vision, indicating the program's effectiveness. The Re:Vision program can be done at home, making it accessible for families who don't live near specialized therapy centers. This accessibility could greatly enhance the quality of life for children with hemianopia. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric Bouffet, MD

Principal Investigator

Hospital of Sick Children

Michael Reber, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39687429/

a single-arm feasibility and proof-of-concept trial Exploratory outcomes revealed a significant positive correlation between the performance at the 3D-MOT-IVR intervention and the visual ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06362434

Study Details | NCT06362434 | Visual Telerehabilitation in ... Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00534-0/fulltext

A telerehabilitation program to improve visual perception in ... A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34354660/

Case Report: Visual Rehabilitation in Hemianopia Patients. ... In this case series, we sought to characterize the feasibility and potential effectiveness of a home-based visual rehabilitation program in ...

5. withpower.com withpower.com/trial/audiovisual-stimulation-for-hemianopia-from-brain-tumors-eebce

Audiovisual Stimulation for Hemianopia from Brain Tumors ... Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9680509/

Visual Field Loss: Integrating Overlayed Information to ... Here we outline a conceptual approach to increasing the amount of useful information by overlaying the blind field into the sighted field.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024005340

A telerehabilitation program to improve visual perception in ... This study aimed to explore the feasibility, safety, and potential effectiveness of a home-based audiovisual stimulation in immersive virtual-reality (3D-MOT- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05065268

Study Details | NCT05065268 | Visual Rehabilitation in ... Several studies demonstrated that these patients could improve visual perception in the damaged hemifield after a stimulation procedure where auditory and ...

9. frontiersin.org frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2014.00082/full

Rehabilitation of homonymous hemianopia: insight into ... Herein we review different visual rehabilitation techniques designed for brain-damaged patients with visual field loss.