Visual Rehabilitation Training for Stroke

Overseen By Evan Burr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Neuroactive medications

Disqualifiers: Ocular disease, Brain injury, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.

Do I need to stop my current medications for the trial?

The trial excludes participants who are currently using neuroactive medications that would impact training, as determined by the principal investigator. It is likely that you may need to stop certain medications, but this will be assessed on a case-by-case basis.

What data supports the effectiveness of this treatment for visual rehabilitation after stroke?

Research shows that visual rehabilitation training significantly improves visual field defects in stroke patients, with trained areas showing more improvement than untrained areas. This training is effective both in the early and chronic phases after a stroke, and it helps patients regain a larger visual field sooner, enhancing their overall visual function. ^{1 2 3 4 5}

How does the Visual Rehabilitation Training for Stroke treatment differ from other treatments for visual field defects?

This treatment is unique because it involves targeted visual training in both the blind and intact fields, which can significantly enhance recovery by stimulating brain plasticity. Unlike other treatments that may focus on spontaneous recovery, this approach actively trains the brain to improve visual field defects, even in chronic phases, by using repetitive visual stimulation. ^{1 2 4 5 6}

Eligibility Criteria

This trial is for US and Canada residents who've had a stroke damaging the primary visual cortex within the last 6 months, leading to reliable vision defects. Participants must be able to undergo MRI scans, speak English fluently, have good enough eyesight (20/40 or better), and can do daily visual training at home.

Inclusion Criteria

I am willing and able to give my consent for treatment.

Fluent in written and spoken English

I had a stroke affecting my vision less than 6 months ago, confirmed by MRI or CT scan.

Exclusion Criteria

I am not on any brain-affecting meds that would interfere with the study.

You have difficulty paying attention to one side of your body or surroundings.

You have brain damage that could make it harder for you to learn or affect the study results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments of visual sensitivity and structural measurements using various perimetry and imaging techniques

1-2 weeks

1 visit (in-person)

Training

Participants undergo visual restoration training using specialized software in both blind and intact fields

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for changes in visual performance and structural aspects post-training

6 months

2 visits (in-person)

Treatment Details

Interventions

• Chronic Training in the blind field
• Subacute Training in the blind field
• Subacute Training in the intact field

Trial Overview The study tests how well different types of visual training help recover sight after a stroke. It involves exercises in both the intact and blind parts of the field of vision, comparing early versus late training effects on brain plasticity and vision restoration.

Participant Groups

Group I: Training in the intact field Experimental Treatment 2 Interventions

Training in the intact field using specialized software

Group II: Training in the blind field Experimental Treatment 2 Interventions

Training in the blind field using specialized software

Chronic Training in the blind field is already approved in United States, European Union for the following indications:

Approved in United States as Visual Rehabilitation Training for:

• Cortical Blindness
• Hemianopia
• Quadranopia

Approved in European Union as Visual Restoration Training for:

• Cortical Blindness
• Visual Field Defects

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study involving 17 subacute stroke patients, visual discrimination training started within 6 weeks after stroke significantly enhanced recovery of visual field defects, contributing about twice as much to defect reduction compared to spontaneous recovery.

The training was effective in both subacute and chronic patients, indicating that early intervention allows patients to access a larger visual field sooner, which is crucial for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Segregation of Spontaneous and Training Induced Recovery from Visual Field Defects in Subacute Stroke Patients. Bergsma, DP., Elshout, JA., van den Berg, AV.[2020]

In a study involving 18 patients with visual field defects, extrastriate vision restoration therapy (VRT) led to a significant 5.9% improvement in stimulus detection, suggesting it effectively activates alternative visual pathways.

The results indicate that extrastriate VRT is more effective than standard VRT, with detection performance improving twice as much after extrastriate training, highlighting its potential to stimulate brain regions involved in blindsight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision restoration through extrastriate stimulation in patients with visual field defects: a double-blind and randomized experimental study. Jobke, S., Kasten, E., Sabel, BA.[2022]

In a study of 19 patients with visual field loss due to cerebral lesions, six months of Vision Restoration Training (VRT) significantly increased visual field size and improved cognitive functions, particularly attention.

The strongest predictor of visual field improvement was the size of areas of residual vision, while demographic and lesion-related factors had minimal impact on training success, suggesting that clinicians can use specific variables to predict training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactorial predictors and outcome variables of vision restoration training in patients with post-geniculate visual field loss. Poggel, DA., Mueller, I., Kasten, E., et al.[2008]

Visual restitution training can help enlarge the visual field in patients with optic nerve or brain injuries, showing average improvements of 5 degrees in vision even years after the injury.

This training is effective for patients with some residual vision and suggests that brain plasticity plays a key role in restoring vision, offering new hope for treating partial blindness previously thought to be irreversible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of vision by training of residual functions. Sabel, BA., Kasten, E.[2019]

Visual restoration therapy can lead to significant changes in brain activity in hemianopic patients, specifically increasing responsiveness in the trained borderzone of their visual field after one month of therapy, as shown by fMRI results.

The therapy appears to shift attention from the nontrained seeing field to the trained borderzone, with key brain areas like the anterior cingulate and dorsolateral frontal cortex playing a crucial role in this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain activity associated with stimulation therapy of the visual borderzone in hemianopic stroke patients. Marshall, RS., Ferrera, JJ., Barnes, A., et al.[2022]

In a study of 26 patients, those who started visual restoration therapy within 12 months after a stroke or trauma showed only modest improvements (8% in computer campimetry and 10-15% in conventional automated perimetry).

Surprisingly, the group that began therapy more than a year after their lesions demonstrated greater improvements (13.5% in campimetry and 20% in perimetry), suggesting that attention deficits immediately following brain damage may hinder early training effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of early and late rehabilitation of stroke and cerebral trauma patients with visual field defects]. Müller, I., Sabel, B., Kasten, E.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Segregation of Spontaneous and Training Induced Recovery from Visual Field Defects in Subacute Stroke Patients. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Vision restoration through extrastriate stimulation in patients with visual field defects: a double-blind and randomized experimental study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Multifactorial predictors and outcome variables of vision restoration training in patients with post-geniculate visual field loss. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Restoration of vision by training of residual functions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Brain activity associated with stimulation therapy of the visual borderzone in hemianopic stroke patients. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Comparison of early and late rehabilitation of stroke and cerebral trauma patients with visual field defects]. [2018]