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

Trial Summary

What is the purpose of this trial?

This is a prospective study that compares biofeedback training on the microperimetry (BT) to a control group in patient s with hemianopia. The patients receive 5 sessions of 20 minutes to stimulate with light and sound the brain in using the best residual area on the visual fields post-brain injury visual loss. Visual tests and quality of life questionnaire are performed pre-and-post-training.

Research Team

MONICA Daibert Nido, Assistant

Principal Investigator

University Healt Network

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+