Vision Training for Cortical Blindness

Overseen By Chrys Callan

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vision training method to improve sight for individuals with vision problems due to a stroke. Initially, the study will involve participants without vision issues to assess the training's effectiveness, followed by those with vision loss from stroke damage. Eligible participants have experienced a stroke affecting their vision and have consistent vision problems in both eyes. As an unphased trial, this study allows participants to contribute to pioneering research that could lead to new treatments for vision loss.

Will I have to stop taking my current medications?

If you are currently taking neuroactive medications (drugs that affect the brain), you may need to stop, as these could impact the training. The decision will be made by the principal investigator (PI) of the study.

What prior data suggests that this visual training paradigm is safe for participants?

Research has shown that vision training and learning tasks have been well-tolerated in past studies. In one study, a 12-week visual training program helped stroke patients improve their vision without major safety issues. Another study found that an 8-week training program improved areas of vision loss in patients who had a stroke long ago. These studies did not report serious side effects, suggesting that the treatment is generally safe.

Previous research on similar visual learning therapies also shows they can improve vision in larger areas of vision loss. While these results are promising, discussing any potential risks with the trial team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vision Training and Learning Task for cortical blindness because it offers a non-invasive approach that focuses on harnessing the brain's ability to adapt and rewire itself, known as neuroplasticity. Unlike traditional treatments that might rely on surgical interventions or medications, this method uses targeted visual exercises to potentially restore some level of vision in individuals who have lost it due to brain injuries. This innovative approach could provide a new avenue for improving visual functions without the risks associated with more conventional methods.

What evidence suggests that this vision training is effective for cortical blindness?

This trial will evaluate the effectiveness of vision training for individuals with cortical blindness. Research has shown that vision training can greatly improve sight in people with cortical blindness due to a stroke. Studies have found that this training can quickly enhance vision in larger areas of the blind field compared to other methods. A review of several studies involving stroke patients with vision problems found significant improvements in their sight. Training methods using statistical learning have also shown promise, making the learning process more effective and easier. Early results suggest that digital therapies focused on improving visual perception could be effective for these conditions, offering hope for meaningful vision recovery. Participants in this trial will join either the cortically blind cohort or the control cohort to assess the impact of visual training. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with vision loss due to stroke, including conditions like hemianopia and partial vision loss. It's open to those who have had either ischemic or hemorrhagic strokes that resulted in visual field defects. The study will first involve people without visual impairments before including stroke survivors.

Inclusion Criteria

Have successfully completed previous enrollment in Dr. Huxlin study (IRB #5966 or #75)

Residents of the United States or Canada

Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey visual fields. This deficit must be large enough to enclose a 5-deg diameter visual stimulus

Exclusion Criteria

History of traumatic brain injury

Cognitive or seizure disorders

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Visual Training

Participants undergo visual training based on statistical learning to improve visual abilities

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vision Training and Learning Task

Trial Overview The trial is testing a new type of visual training based on statistical learning theories. The goal is to improve vision with less training effort. Initially, the method will be tested on people with normal vision, then on those affected by stroke-related visual issues.

How Is the Trial Designed?

Group I: Visual Training in Cortically Blind cohort Experimental Treatment 1 Intervention

Group II: Visual Training in Control cohort Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775322/

Training in cortically-blind fields confers patient-specific ... We performed a meta-analysis of optical coherence tomography (OCT) data in 48 participants with unilateral V1 stroke and homonymous visual defects, who ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06578117

Statistical Learning As a Novel Intervention for Cortical ... This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual ...

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

Rehabilitation of visual perception in cortical blindness It improved vision faster, over larger portions of the blind field, and for a larger number of visual discrimination abilities than identical training initiated ...

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

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

5. j-stroke.org j-stroke.org/upload/pdf/jos-2023-00276.pdf

Digital Therapeutics With Visual Discrimination Training for ... These findings suggest the potential effectiveness of digi- tal therapeutics with VPL training in patients with cortical blind- ness, which warrants future ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4795973/

Re-learning to see in cortical blindness - PMC - PubMed Central Here we summarize recent developments in the still emerging field of visual restitution therapy, and compare the relative effectiveness of different approaches.

7. 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.

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

Customized Visual Discrimination Digital Therapy ... We investigated the efficacy of our 8-week VFD-customized visual discrimination training protocol in improving VFDs of chronic stroke patients ...