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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests biofeedback training as a new method to assist individuals with hemianopia, a condition where brain injury causes loss of vision in half of the visual field. The goal is to determine if this training can teach patients to move their eyes in ways that enhance their vision. Participants will be divided into two groups: one will receive the training, while the other will only undergo assessments. Individuals diagnosed with hemianopia who can follow visual and auditory instructions may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve vision rehabilitation techniques.

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 prior data suggests that this biofeedback training technique is safe for vision rehabilitation?

Research has shown that biofeedback training (BT) is generally safe for people with vision loss. Studies on BT for vision problems have found it to be well-tolerated with few side effects. For example, patients using BT for central vision loss and similar conditions experienced positive results without major safety concerns. Since BT is non-invasive, it doesn't involve surgery or medication, which usually means fewer risks. Overall, previous research suggests that BT is a safe option for those with vision issues like hemianopia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about biofeedback training for hemianopia because it offers a non-invasive approach that could enhance visual processing. Unlike traditional treatments, which often focus on compensatory strategies like visual scanning training, biofeedback uses real-time feedback to help patients retrain their brains to improve vision. This method may help patients tap into their own neural plasticity, potentially leading to more natural and lasting improvements in their visual field. By harnessing the brain's ability to adapt, biofeedback training could represent a significant shift in managing hemianopia, sparking hope for more effective rehabilitation.

What evidence suggests that biofeedback training is effective for hemianopia?

In this trial, participants in Group A will receive biofeedback training, which has shown promise in previous studies. One study with 21 patients who had hemianopia found that biofeedback training over four weeks helped them better notice and respond to visual signals. Research shows that biofeedback training, often used for people with central vision loss, may also improve vision in those with hemianopia. Other studies have found that 10 to 25 training sessions over six weeks can be effective for people with hemianopia. This training teaches patients to move their eyes in a way that brings the blind area into view, improving their vision. These findings suggest biofeedback training could be a helpful tool for vision rehabilitation in people with hemianopia. Participants in Group B will not receive the intervention but will perform the same tests for assessment as in Group A. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

You have been diagnosed with hemianopia using specific eye tests.

I can see, hear, and follow instructions well.

I can follow visual and auditory instructions.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05397873

Biofeedback for Hemianopia Vision Rehabilitation Conventional visual exploration training studies have confirmed that 10 to 25 training sessions in a 6-week period can be effective for hemianopia patients to ...

2. withpower.com withpower.com/trial/phase-injuries-brain-6-2021-3f9bd

Biofeedback Training for Hemianopia 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06638619?term=AREA%5BConditionSearch%5D(Hemianopia)&rank=3

Comparative Efficacy of Saccadic and Biofeedback ... This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10126773/

Innovative vision rehabilitation method for hemianopsia ... We investigated the effectiveness of biofeedback training (BT), used for vision rehabilitation in patients with central vision loss, in individuals with HH.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37114220/

Innovative vision rehabilitation method for hemianopsia ... We investigated the effectiveness of biofeedback training (BT), used for vision rehabilitation in patients with central vision loss, in individuals with HH.

6. 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- ...