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Biofeedback for Hemianopia Vision Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05397873
Recruitment Status : Recruiting
First Posted : May 31, 2022
Last Update Posted : May 31, 2022
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Monica Nido, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Hemianopsia, Homonymous Brain Injury Stroke Brain Tumor Brain Trauma Device: Biofeedback training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A group of patients have the intervention and another group has control tests. The control group crosses over to the interventional group
Masking: Single (Outcomes Assessor)
Masking Description: The assessor does not know if the patient is in the control group, treatment group or cross over group.
Primary Purpose: Treatment
Official Title: Biofeedback Training to Improve Fixation Stability, Visual Function Outcomes, and Quality of Life in Hemianopia Cases
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Arm Intervention/treatment
Experimental: Group A
The patients will undergo baseline assessment and receive the intervention, being assessed after the intervention.
Device: Biofeedback training
The training of oculomotor functions is done on the biofeedback module of a microperimeter MAIA.

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.



Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 1 week post biofeedback ]
    ETDRS best corrected visual acuity

  2. Fixation stability [ Time Frame: 1 week post biofeedback ]
    As measure by the MAIA microperimeter at the BCEA 63% ellipse area.

  3. Retinal sensitivity [ Time Frame: 1 week post biofeedback ]
    Paracentral (2 central vertical columns) and total average in dB as measured by the MAIA microperimeter.

  4. Reading speed [ Time Frame: 1 week post biofeedback ]
    As measured with the MNRead charts

  5. Near vision [ Time Frame: 1 week post biofeedback ]
    Measured with the Colenbrander 100% charts

  6. Quality of Life Questionnaire scores [ Time Frame: 1 week post biofeedback ]
    As measured with the Massof - 48 questionnaire


Secondary Outcome Measures :
  1. Stereopsis [ Time Frame: 1 week post biofeedback ]
    As measured with the Frisby stereotest

  2. Contrast Sensitivity [ Time Frame: 1 week post biofeedback ]
    As measured with the F.A.C.T. test at 1m



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05397873


Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: MONICA DAIBERT NIDO, MD    4166035470    monica.nido@uhn.ca   
Contact: Monica Daibert Nido, MD    4164819995      
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Publications:
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Responsible Party: Monica Nido, Assistant Professor, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05397873    
Other Study ID Numbers: University of Toronto
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monica Nido, University Health Network, Toronto:
hemianopsia
stroke
brain tumor
brain trauma
visual fields
visual loss
low vision
fixation stability
biofeedback training
MAIA microperimeter
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Injuries
Hemianopsia
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Blindness
Eye Diseases