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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a training program for individuals who have lost vision due to a stroke. The goal is to determine if specific exercises can improve vision or ease adaptation to vision changes post-stroke. Participants will train either in the affected part of their vision (Chronic Training in the blind field) or the unaffected part (Subacute Training in the intact field). Ideal candidates are those who experienced a stroke affecting their vision within the last six months and can engage in daily home training. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation strategies for stroke survivors.

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 prior data suggests that this visual rehabilitation training is safe?

Research has shown that visual rehabilitation training is generally safe for individuals with cortical blindness, which results from brain damage. Studies on visual restoration methods have found these training techniques to be well-tolerated, with no significant side effects commonly reported.

For example, one study used visual perceptual learning, a method to enhance visual perception, and found improvements in vision after 12 weeks of training, with no major safety concerns. Another study demonstrated that combining vision restoration training with other methods in early-stage stroke patients was safe and well-received.

These findings suggest that the training methods under study are likely safe for participants. However, as with any new treatment, monitoring for potential issues remains important. Overall, existing research supports the safety of these rehabilitation techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these visual rehabilitation training methods because they offer a targeted approach to improving vision after a stroke. Unlike traditional therapies that often focus on compensatory strategies, such as using the intact visual field or relying on assistive devices, these new methods directly engage the brain's ability to adapt and retrain itself. By using specialized software to train in both the blind and intact fields, these techniques aim to restore visual function more effectively by promoting neuroplasticity—essentially, the brain's ability to reorganize and heal. This innovative approach could bring about more comprehensive and lasting improvements in vision for stroke survivors.

What evidence suggests that this trial's treatments could be effective for visual rehabilitation after stroke?

Research has shown that visual training can help stroke patients regain some vision in areas where they have lost sight. In this trial, participants will be assigned to different training arms. One arm involves training in the blind field, where patients practice visual exercises in their blind spots. In one study, patients who practiced such exercises regained about 108 square degrees of vision on average, while those who did not practice regained only 16 square degrees. This suggests that visual training can lead to significant improvements in vision. Another arm involves training in the intact field, where studies have found that starting training soon after a stroke can enhance abilities like detecting movement and sensitivity to light. These findings highlight the potential benefits of visual training for people who have lost vision due to a stroke. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9682408/

Rehabilitation of visual perception in cortical blindness - PMC While visual training does recover chronic stroke patients' ability to perform a range of detection and discrimination tasks in their blind field, recovery ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/B9780128194102000308

Rehabilitation of visual perception in cortical blindness Here, we review the different approaches to rehabilitation employed in adult-onset cortical blindness (CB), focusing on visual restoration methods.

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2016.00092/full

Visual Rehabilitation in Chronic Cerebral Blindness In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000003921

Visual discrimination training improves Humphrey ... Trained patients recovered ∼108 degrees2 of vision on average, while untrained patients spontaneously improved over an area of ∼16 degrees2. Improvement was not ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11537328/

Persistence of training-induced visual improvements after ... The present findings underscore the potential of extended visual training to induce long-term improvements in stroke-induced vision loss.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03160131

Rehabilitation of Visual Function After Brain Injury Neuro Vision Technology (NVT) is an supervised training course where people with visual impairments are trained in compensatory techniques using special ...

7. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2024.0015

Customized Visual Discrimination Digital Therapy ... Visual perceptual learning (VPL) may improve visual field defects (VFDs) after chronic stroke, but the optimal training duration and ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834246

Personalized Visual Perceptual Learning Digital Therapy ... The 12-week training session, which used visual perceptual learning, effectively enhanced visual field defect recovery in poststroke patients.