Recruiting

Biofeedback Training

Sponsor:

University Health Network, Toronto

Code:

NCT06995313

Conditions

Hemianopia

Brain Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biofeedback training

Study Details

Brief summary:

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.

Conditions

Hemianopia

Brain Injuries

Study ID

NCT06995313

Start date

Dec 8, 2021

Status verified date

May, 2025

Completion date

Jul 8, 2026

Anticipated

Primary completion date

Jul 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Hemianopia cases with more than 6 months from the date of the lesion, previously diagnosed accordingly by micro perimetry and other tests as needed, 18-90 years old, ability to follow the visual and auditory stimuli and training instructions.

Exclusion Criteria:

Previous or current treatment for low vision rehabilitation, ocular diseases, other serious clinical conditions not related to the hemianopia, both eyes with media opacity that impairs microperimetry testing, lack of ability to perform the tests and training.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

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

no intervention: Group B

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

Interventions

Biofeedback training

This is an audio-luminous stimulation on the micro perimeter that teaches the brain to use a different fixation locus on the retinal other than the fovea and develops visual attention to the surrounding retinal areas. 20 minutes exercises for stimulation are performed on the micro perimeter, once a week, for 5 weeks.

Primary outcome measure

  • Retinal sensitivity [ Time Frame: Pre- intervention and 1 month post-intervention. ]

Central Contacts and Locations

Central contacts

Monica Daibert-Nido, MD

4166035800lowvisionuhn@gmail.com

Clarice Mediana, Assistant

4166035800lowvisionuhn@gmail.com

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Clarice Mediana, Assistant

4166035800lowvisionuhn@gmail.com

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 29, 2025

Last verified

May, 2025

Keywords

  • hemianopsia
  • biofeedback training
  • brain tumor
  • brain trauma
  • visual fields
  • visual loss
  • low vision
  • fixation stability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-05-29.