Biofeedback Training for Hemianopia

Overseen By Monica Daibert Nido, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Ocular diseases, Media opacity, others

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

Compensation: Varies

Number of Visits: 5

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Biofeedback Training (BT) for patients with vision loss on one side due to brain injury. BT uses real-time feedback like sounds or lights to help patients improve their eye movements. This can help them see better by bringing visual information from their blind side into their seeing side. Biofeedback has been explored for various eye conditions and visual impairments, showing potential in improving visual functions.

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, if you are receiving treatment for low vision rehabilitation, you may not be eligible to participate.

What data supports the effectiveness of the treatment Biofeedback training for Hemianopia?

Research shows that biofeedback training, which helps improve eye movement and visual functions, has been effective in vision rehabilitation for people with central vision loss and low vision conditions. This suggests it could also help those with hemianopia, a condition where half of the visual field is lost. ^{1 2 3 4 5}

Is biofeedback training generally safe for humans?

Biofeedback training has been used in various studies for vision rehabilitation in conditions like low vision and macular diseases, and no significant safety concerns have been reported in these studies. ^{1 3 4 6 7}

How does biofeedback training differ from other treatments for hemianopia?

Biofeedback training for hemianopia is unique because it uses audio-luminous feedback to improve eye movement and visual functions, which helps patients better scan and orient themselves in their environment. Unlike other treatments, it focuses on enhancing the patient's ability to use their remaining vision effectively, rather than attempting to restore lost vision. ^{1 3 4 8 9}

Eligibility Criteria

This trial is for individuals aged 18-90 with hemianopia, a type of vision loss after brain injury from stroke, surgery, or trauma. Participants must be able to follow visual and auditory instructions but haven't had low vision rehabilitation before.

Inclusion Criteria

I am between 18 and 90 years old.

You have been diagnosed with hemianopia using specific eye tests.

I can see, hear, and follow instructions well.

Exclusion Criteria

I have serious health issues not related to my partial blindness.

I am unable to perform certain tests or training.

Both of my eyes have a condition that affects certain vision tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment to evaluate visual acuity, stereopsis, contrast sensitivity, and other visual functions

1 week

Biofeedback Training

Participants receive biofeedback training to improve oculomotor control and fixation stability

6 weeks

5 weekly sessions of 20 minutes each

Follow-up

Participants are monitored for improvements in visual acuity, reading speed, and quality of life post-training

1 week

Treatment Details

Interventions

• Biofeedback training

Trial Overview The study tests biofeedback training (BT) as a new technique for improving eye movement control in people with hemianopia. It aims to help patients adapt by learning to shift their gaze into the blind field of vision.

Participant Groups

Group I: Group A Experimental Treatment 1 Intervention

The patients will undergo baseline assessment and receive the intervention, being assessed after the intervention.

Group II: Group B Active Control 1 Intervention

The patients will perform the same tests for assessment as in group A, however, no intervention will be done. They may enrol in the study as group B after completing group B participation.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Findings from Research

In a study involving 17 patients with central vision loss due to macular disease, MP-3 microperimeter biofeedback fixation training significantly improved best corrected visual acuity, reading speed, and mean central sensitivity after 20 weeks of rehabilitation.

The training also enhanced fixation stability, as indicated by increased percentages of fixation points within specified regions and improved scores on the National Eye Institute visual function questionnaire, suggesting a positive impact on the patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of MP-3 microperimeter biofeedback fixation training for low vision rehabilitation in patients with maculopathy. Qian, T., Xu, X., Liu, X., et al.[2022]

In a study of 35 patients with central scotoma, visual rehabilitation using microperimeter biofeedback significantly improved fixation stability and reading performance after just 10 training sessions.

Patients also reported enhanced quality of life, as indicated by increased scores on the National Eye Institute Visual Function Questionnaire, demonstrating the overall efficacy of this rehabilitation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Low Vision Rehabilitation Using Microperimetric Acoustic Biofeedback Training in Patients with Central Scotoma. Sahli, E., Altinbay, D., Bingol Kiziltunc, P., et al.[2021]

In a study of 21 patients with hemianopia, 4 weeks of compensatory visual field training significantly improved their ability to detect and react to visual stimuli when using exploratory eye movements, with these improvements lasting for 8 months.

Despite the training enhancing visual detection and reaction times, the actual size of the visual field defect (scotoma) did not change, indicating that the training improved functional abilities without restoring the lost visual field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensatory visual field training for patients with hemianopia after stroke. Nelles, G., Esser, J., Eckstein, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Innovative vision rehabilitation method for hemianopsia: Comparing pre- and post audio-luminous biofeedback training for ocular motility improving visual functions and quality of life. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of vision rehabilitation treatment through MP-1 microperimeter in patients with visual loss due to macular disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A new method of biofeedback in the management of low vision. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of MP-3 microperimeter biofeedback fixation training for low vision rehabilitation in patients with maculopathy. [2022]

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

Effectiveness of Low Vision Rehabilitation Using Microperimetric Acoustic Biofeedback Training in Patients with Central Scotoma. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Visual outcomes of audio-luminous biofeedback training for a child with idiopathic nystagmus. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Low-vision rehabilitation by means of MP-1 biofeedback examination in patients with different macular diseases: a pilot study. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Compensatory visual field training for patients with hemianopia after stroke. [2022]

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

Biofeedback enhanced strabismus therapy. [2009]