Recruiting

Biofeedback

Sponsor:

University Health Network, Toronto

Code:

NCT05397873

Conditions

Hemianopsia, Homonymous

Brain Injury

Stroke

Brain Tumor

Brain Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biofeedback training

Study Details

Brief summary:

Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. Classic and effective saccadic compensatory training therapies are current aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind hemifield into the seeing hemifield for further processing. Patients learn, therefore, to efficiently use their eyes "to keep the 'blind side' in sight". Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.

Conditions

Hemianopsia, Homonymous

Brain Injury

Stroke

Brain Tumor

Brain Trauma

Study ID

NCT05397873

Start date

Dec 1, 2021

Status verified date

May, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Apr 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • hemianopia cases previously diagnosed accordingly by microperimetry 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 physiopathology
  • both eyes with media opacity that impairs microperimetry testing
  • lack of ability to perform the tests and training

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

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

no intervention: Group B

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.

Interventions

Biofeedback training

The training of oculomotor functions is done on the biofeedback module of a microperimeter MAIA.

Primary outcome measure

  • Visual Acuity [ Time Frame: 1 week post biofeedback ]
  • Fixation stability [ Time Frame: 1 week post biofeedback ]
  • Retinal sensitivity [ Time Frame: 1 week post biofeedback ]
  • Reading speed [ Time Frame: 1 week post biofeedback ]
  • Near vision [ Time Frame: 1 week post biofeedback ]
  • Quality of Life Questionnaire scores [ Time Frame: 1 week post biofeedback ]

Central Contacts and Locations

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

MONICA DAIBERT NIDO, MD

4166035470monica.nido@uhn.ca

Monica Daibert Nido, MD

4164819995

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 9, 2025

Last verified

May, 2025

Keywords

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

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 2025-05-09.