ClinicalTrials.gg
RecruitingNCT05397873Updated May 9, 2025

Biofeedback for Hemianopia Vision Rehabilitation

An interventional study of Biofeedback training in Hemianopsia, Homonymous, Brain Injury and Stroke, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Background

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. About 45% of stroke survivors have homonymous hemianopia. A deficit in vision and spatial perception can cause slowdown of the rehabilitation progress in physiotherapy.

According to Kerkhoff 1patients face three main visual behavioral problems: (1) impaired eye movements (including saccades) leading to defective visual and spatial exploration, (2) hemianopic reading deficit (hemianopic alexia) because of the parafoveal field loss and (3) deviated subjective midline. Hemianopic dyslexia is not simply the product of the visual field defect but is caused by a disorder of control of visual information processing and eye movements in reading.

Most important, the capability to read is fundamental for daily living and an essential prerequisite for education and success in our modern society, so this disorder can have a profound effect on patients' lives. Patients with visual field loss usually fail to adapt to their reading impairment (80% of cases). In these cases, word identification and the abilities to plan and guide reading eye movements are disturbed.

In spite of these facts, visual rehabilitation program on a larger scale is still missing in most rehabilitation centers and clinics. This is decurrent to the generalized belief that lesions of the lateral geniculate nucleus and striate cortex lead to a permanent loss of vision. According to scientific findings, this does not always have to be true.

Classic and effective saccadic compensatory training therapies are current.5 They 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. Such therapies involve the systematic and repetitive practice of specific eye movements for reading or for visual exploration. 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". The training-induced, efficient oculomotor adaptation to visual field loss becomes manifest as a change of reading (or visual exploration) eye-movement patterns and indicates the functional reorganization of the control of visual information processing and eye movements.6

Biofeedback training for active eye movement control was never used in hemianopia cases before. 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.7-9 Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.10-18 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.

Rationale for the study

The deviation of the subjective midline in hemianopia cases brings visual perception from a line of objects in the surrounds to be at a much higher-level of perception/cognition, thus disturbing reading, gait and balance. Besides that, impaired saccades also cause wrong exploration patterns and deteriorated visual search. It results in the prolonged exploration time of a scene and can lead to significant problems in daily life such as inability to navigate around various obstacles (cars, people and other objects). It also causes a cognitive deficit while extracting information from a visual scene. 1 A combination of factors such as reduced contrast sensitivity, impaired visual search and inaccurate fixation contributes to the matter.

Visual information extraction from the parafoveal visual field provides the basis for planning and guiding of reading eye movements. Therefore, patients with hemianopia have difficulties in shifting their gaze systematically from left to right (in right-sided field loss) or finding the beginning of a new line (in left sided field loss). Such eye movements are optimized by visual feedback. BT promotes luminous and auditory biofeedback, which potentializes its efficacy in vision rehabilitation.

BT in the microperimeter module provides the accurate and efficient oculomotor training necessary to relocate the subjective midline to the seeing field in 1-20 or even more, as needed. BT also improves dramatically fixation stability and saccades. The advantage of this training method over classic training is potentially great. Firstly, the highest retinal sensitivity convenient point can be identified considering the whole visual field. The microperimeter provides real time scrutiny of ocular movements on a screen, and the therapist is able to select precisely the trained retinal locus (FFT) to be used by the patient on top of the microperimeter visual field. Finally, according to the patients' response the FFT can be readjusted. Eight cases trained with BT for hemianopia in our low vision rehabilitation (LVR) service had marked improvements in fixation stability, and microperimeter fields.

Expansion of visual space in the direction of the blind field and compression of visual space in the direction of the seeing field may be a contributory factor to the altered perception of their egocentric directional sense and overall more veridical mapping of their visual space, as well as the resultant shift in their positional centre of gravity. We hypothesize that BT promotes this field relocation.

Conventional visual exploration training studies have confirmed that 10 to 25 training sessions in a 6-week period can be effective for hemianopia patients to adopt these strategies. BT is able to achieve significant results in 5 weekly sessions of 20 minutes each, according to 8 cases treated in our service.

Study hypothesis

The visual and audio parts of the BT program improve in a synergistic way oculomotor control through attention improvement and volitional eye movements towards pre-designated targets. Improved oculomotor control results in better fixation stability of eyes. Better fixation stability in turn results in better navigation for distance and near vision reading. Dual sensory BT is a therapy used in low vision for more than ten years, showing good results for near and distance vision in cases with macular degeneration and other pathologies. The study hypothesis, never tested before, is that BT in cases with hemianopia will impact positively oculomotor control and visual acuity as it was proven to do in cases with macular degeneration.

Significance of the study

Vision is a major sensory input to the human brain. Half of the afferent neuronal fibers projecting to the brain originate from the eyes. Intact visual abilities are an important condition enabling us to orient ourselves in our world. Pambakian and Kennard 20 reported that 50% of all neurological admissions into hospitals in the United Kingdom are due to a stroke and 30% percent of them are reported to have hemianopia.

Numbers of hemianopic patients reported in the Czech Republic are similar and somewhat lower due to differences in diagnostics and classification of nosological units.21 Visual impairments are present in 20 to 40% of patients in neurological rehabilitation centers.

If brain visual plasticity is possible to be achieved from conventional vision training methods, specialized training with BT needs to be investigated as a tool to improve significantly a cortical visual disorder. There is need for simple and more effective visual training which could be used in LVR in large scale for hemianopia cases. Furthermore, BT needs to be evaluated in terms of quality of life (QoL) improvement to the patients.

The objectives set for this trial is to verify if BT impacts on oculomotor control in cases with hemianopia and results in better fixation stability, reading speed and QoL in those trained with BT.

02

Conditions studied

  • 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
03

In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's planned enrollment of 32 is close to the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Group A

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

    Device: Biofeedback training

  • 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

  • DeviceBiofeedback training

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

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    ETDRS best corrected visual acuity

    Time frame: 1 week post biofeedback

  2. Fixation stability

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

    Time frame: 1 week post biofeedback

  3. Retinal sensitivity

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

    Time frame: 1 week post biofeedback

  4. Reading speed

    As measured with the MNRead charts

    Time frame: 1 week post biofeedback

  5. Near vision

    Measured with the Colenbrander 100% charts

    Time frame: 1 week post biofeedback

  6. Quality of Life Questionnaire scores

    As measured with the Massof - 48 questionnaire

    Time frame: 1 week post biofeedback

Secondary outcomes

  1. Stereopsis

    As measured with the Frisby stereotest

    Time frame: 1 week post biofeedback

  2. Contrast Sensitivity

    As measured with the F.A.C.T. test at 1m

    Time frame: 1 week post biofeedback

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Kerkhoff G. Restorative and compensatory therapy approaches in cerebral blindness - a review. Restor Neurol Neurosci. 1999;15(2-3):255-71. PubMed 12671237 ↗
  • 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. PubMed 24911923 ↗
  • 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. PubMed 29784180 ↗
  • 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. PubMed 31109472 ↗
  • 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. PubMed 33567015 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: 2021 to 2026

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Apr 2026, 52 months after the start.

Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's planned 52 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2021
First posted
May 31, 2022
StartActual
Dec 1, 2021
Primary completionEst.
Apr 29, 2026
CompletionEst.
Jul 2026
Last update
May 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05397873
Responsible party
Monica Nido (Associate Professor, University Health Network, Toronto) — Principal investigator
First posted
May 31, 2022
Start date
Dec 1, 2021
Primary completion
Apr 29, 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion