Biofeedback for Hemianopia Vision Rehabilitation

NCT05397873 | Recruiting

• 1 other identifier: University of Toronto
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Visual Acuity

  ETDRS best corrected visual acuity

  1 week post biofeedback

• Fixation stability

  As measure by the MAIA microperimeter at the BCEA 63% ellipse area.

  1 week post biofeedback

• Retinal sensitivity

  Paracentral (2 central vertical columns) and total average in dB as measured by the MAIA microperimeter.

  1 week post biofeedback

• Reading speed

  As measured with the MNRead charts

  1 week post biofeedback

• Near vision

  Measured with the Colenbrander 100% charts

  1 week post biofeedback

• Quality of Life Questionnaire scores

  As measured with the Massof - 48 questionnaire

  1 week post biofeedback

Secondary Outcomes (2)

• Stereopsis

  1 week post biofeedback

• Contrast Sensitivity

  1 week post biofeedback

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: Biofeedback training

Group B

NO 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.

Interventions

Biofeedback training DEVICE

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

Group A

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemianopia cases previously diagnosed accordingly by microperimetry and other tests as needed
• years old
• ability to follow the visual and auditory stimuli and training instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Related Publications (5)

• Kerkhoff G. Restorative and compensatory therapy approaches in cerebral blindness - a review. Restor Neurol Neurosci. 1999;15(2-3):255-71.

  PMID: 12671237 BACKGROUND

• Bansal S, Han E, Ciuffreda KJ. Use of yoked prisms in patients with acquired brain injury: a retrospective analysis. Brain Inj. 2014;28(11):1441-6. doi: 10.3109/02699052.2014.919527. Epub 2014 Jun 9.

  PMID: 24911923 BACKGROUND

• Nido MD, Markowitz SN. Vision rehabilitation with biofeedback training. Can J Ophthalmol. 2018 Jun;53(3):e83-e84. doi: 10.1016/j.jcjo.2017.11.003. Epub 2017 Dec 21. No abstract available.

  PMID: 29784180 BACKGROUND

• Daibert-Nido M, Patino B, Markowitz M, Markowitz SN. Rehabilitation with biofeedback training in age-related macular degeneration for improving distance vision. Can J Ophthalmol. 2019 Jun;54(3):328-334. doi: 10.1016/j.jcjo.2018.10.016. Epub 2019 Apr 2.

  PMID: 31109472 BACKGROUND

• Daibert-Nido M, Pyatova Y, Markowitz M, Markowitz SN. Visual outcomes of audio-luminous biofeedback training for a child with idiopathic nystagmus. Arq Bras Oftalmol. 2021 Mar-Apr;84(2):179-182. doi: 10.5935/0004-2749.20210026.

  PMID: 33567015 BACKGROUND

MeSH Terms

Conditions

Hemianopsia; Brain Injuries; Stroke; Brain Neoplasms; Brain Injuries, Traumatic; Vision Disorders; Vision, Low

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor does not know if the patient is in the control group, treatment group or cross over group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A group of patients have the intervention and another group has control tests.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: May 31, 2022
• Study Start: December 1, 2021
• Primary Completion: April 29, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2021 to 2026

Locations

CA (1)