Biofeedback Training for Hemianopia

Overseen By Clarice Mediana, Assistant

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: 13

Duration: 5 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if biofeedback training can enhance vision and quality of life for individuals with hemianopia, a condition where half of the visual field is lost, often due to brain injury. Participants will be divided into two groups: one will receive biofeedback training with light and sound, while the other will not receive any training. The study seeks individuals who have had hemianopia for more than six months and have not received treatment for low vision rehabilitation.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for improving life with hemianopia.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that biofeedback training is safe for patients with hemianopia?

Research has shown that biofeedback training is generally safe for people with vision loss. Studies report that this treatment is well-tolerated, with no major safety concerns. Although some studies have noted issues like difficulty focusing during vision tests, these do not pose significant risks to participants. Overall, the treatment uses light and sound to help train the brain and has been used safely in people with similar vision problems. ^{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 potentially improve vision by retraining the brain's response to visual stimuli. Unlike traditional treatments that may rely on optical aids or compensatory strategies, this technique uses real-time feedback to help patients actively engage their visual fields. This innovative method could lead to more natural vision restoration and enhance the quality of life for individuals with hemianopia.

What evidence suggests that biofeedback training is effective for hemianopia?

Studies have shown that biofeedback training can help people with hemianopia, a condition where part of the vision is lost due to brain injury. One study found that patients who received four weeks of visual training significantly improved their ability to see and react to their surroundings. Another study discovered that after 10 to 25 training sessions, patients became better at visually exploring their environment. This trial will test biofeedback training, which helps the brain maximize remaining vision to improve daily activities, like reading or moving around. Overall, biofeedback training is proving to be a promising way to enhance vision and quality of life for those with hemianopia. ^{1 2 3 4 6}

Who Is on the Research Team?

MONICA Daibert Nido, Assistant

Principal Investigator

University Healt Network

Are You a Good Fit for This Trial?

This trial is for individuals who have lost part of their field of vision, known as hemianopia or quadrantanopia, due to a brain injury. Participants should be able to attend five training sessions and complete visual tests and questionnaires.

Inclusion Criteria

I was diagnosed with hemianopia over 6 months ago.

I am between 18 and 90 years old.

I can see, hear, and follow instructions well.

Exclusion Criteria

I have had eye diseases in the past.

I have received treatment for improving my low vision.

Presence of other serious clinical conditions not related to the hemianopia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments including visual acuity, retinal sensitivity, and quality of life estimates

1 hour

1 visit (in-person)

Treatment

Participants receive biofeedback training for 5 weeks, 20 minutes each session

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

Long-term Follow-up

Participants are followed for long-term outcomes of the biofeedback treatment

24 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback Training

Trial Overview The study is testing biofeedback training using light and sound to improve the use of remaining vision in patients with visual loss after a brain injury. It compares this method against a control group over five 20-minute sessions.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 1 Intervention

This group will receive biofeedback training for 5 weeks in a row, 20 minutes. each session, on the micro perimeter.

Group II: Group B Active Control 1 Intervention

This group will perform the same assessment tests in parallel with Group A and no intervention will be given.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

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. 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.

3. trialx.com trialx.com/clinical-trials/listings/298642/biofeedback-training-for-hemianopia/?&geo_lat=43.732256&geo_lng=-79.493385&radius=10&place=Downsview&user_country=Canada

Biofeedback Training for Hemianopia The training-induced, efficient oculomotor adaptation to visual field loss becomes manifest as a change of reading (or visual exploration) ...

4. 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 ...

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

A telerehabilitation program to improve visual perception in ... The visual field results of four participants were deemed invalid due to a high loss of fixation (>20%). This compromises the robustness of the clinical study ...