Prism Adaptation Therapy for Stroke-Related Perceptual Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Other neurologic, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Prism Adaptation Therapy to assist individuals with spatial awareness difficulties following a stroke on the right side of the brain. Researchers aim to determine if this therapy can improve symptoms for those with spatial neglect, which involves difficulty noticing things on one side. They also seek to identify if specific brain damage patterns predict who benefits most from the therapy. Individuals who have experienced a right hemisphere stroke within the last month and struggle with spatial awareness might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Prism Adaptation Therapy is safe for stroke-related perceptual disorders?

Research shows that Prism Adaptation Therapy (PAT) has been safely used in studies with both healthy individuals and stroke patients. No safety concerns have been reported. As a non-invasive treatment, PAT does not involve surgery or entering the body, making it generally easy to tolerate. Overall, current studies suggest that PAT is a safe option for those considering clinical trials for perceptual disorders after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prism Adaptation Therapy is unique because it offers a non-invasive approach to address stroke-related perceptual disorders. Unlike conventional therapies that might rely on medications or extensive rehabilitation exercises, this therapy involves wearing special glasses that shift the visual field, helping the brain recalibrate and improve perception. Researchers are excited because it targets neuroplasticity, the brain's ability to reorganize itself, which could lead to faster and potentially more effective recovery in just a few sessions.

What evidence suggests that Prism Adaptation Therapy is effective for stroke-related perceptual disorders?

Prism Adaptation Therapy (PAT), which participants in this trial will receive, has been shown to help people with spatial neglect, a condition where they may not notice things on one side of their vision. Research shows that patients with spatial neglect who undergo this therapy often find it easier to perform daily tasks and think more clearly. A review of several studies found that PAT positively affects spatial awareness for those recovering from a stroke. This treatment appears promising for helping individuals regain better control and awareness of their surroundings. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who've had a right hemisphere stroke within the last month and are suspected of having spatial neglect. They must be able to consent, sit for an hour, point straight ahead, hold a pen with their right hand, and undergo MRI scans. They should not have other conditions affecting testing or training ability.

Inclusion Criteria

I will be or have been admitted to Craig H. Neilson Rehabilitation Hospital for therapy.

I can sit in a chair for at least an hour.

You are able to have a MRI scan.

Exclusion Criteria

You don't have uncorrected vision or hearing problems, except for hemianopsia.

You have a medical condition that makes it unsafe for you to have an MRI scan.

Unable to provide consent due to significant aphasia or cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretesting

Pretesting for type of neglect and its severity, followed by MRI with Diffusion Tensor Imaging (DTI)

1 week

Treatment

Participants complete 10 sessions of Prism Adaptation Therapy

2 weeks

10 sessions (in-person)

Post-testing

Neglect post-testing to assess response to Prism Adaptation Therapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prism Adaptation Therapy

Trial Overview The study is looking at how effective Prism Adaptation Therapy is in treating spatial neglect caused by right hemisphere strokes. It aims to identify if brain damage patterns can predict the type of neglect and response to this therapy.

How Is the Trial Designed?

Group I: Prism Adaptation Therapy Experimental Treatment 1 Intervention

10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy

Prism Adaptation Therapy is already approved in United States for the following indications:

Approved in United States as Prism Adaptation Therapy for:

• Spatial neglect following right brain stroke
• Rehabilitation for stroke survivors with spatial neglect

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Prism adaptation treatment (PAT) was found to be more effective in improving neglect symptoms, as measured by the Kessler Foundation Neglect Assessment Process (KF-NAP), in patients with right-sided spatial neglect compared to those with left-sided neglect.

Despite the differences in neglect symptom improvement, both groups showed similar outcomes in overall functional independence, indicating that PAT is beneficial for patients with spatial neglect regardless of the side of the brain lesion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prism Adaptation Treatment for Right-Sided and Left-Sided Spatial Neglect: A Retrospective Case-Matched Study. Rich, TJ., Pylarinos, M., Parrott, D., et al.[2023]

Prism adaptation (PA) is a non-invasive technique that may help in rehabilitating neglect symptoms after right-hemisphere lesions, but its effectiveness in treating complex regional pain syndrome (CRPS) is still unclear due to insufficient data.

There is no consensus on whether CRPS patients exhibit neglect-like symptoms, and further research is needed to explore the relationship between PA and pain modulation, as well as to refine the assessment of neglect in various types of chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prisms for pain. Can visuo-motor rehabilitation strategies alleviate chronic pain? Torta, DM., Legrain, V., Rossetti, Y., et al.[2022]

In a study of 355 stroke patients, 23.7% were found to have spatial neglect (SN), which negatively impacted their functional recovery and independence, regardless of whether they received prism adaptation treatment (PAT).

However, patients with SN who underwent PAT showed similar rehabilitation gains as those without SN, suggesting that integrating PAT into intensive rehabilitation can help mitigate the adverse effects of SN on recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prism Adaptation Treatment Predicts Improved Rehabilitation Responses in Stroke Patients with Spatial Neglect. Vilimovsky, T., Chen, P., Hoidekrova, K., et al.[2022]

Prism Adaptation Therapy (PAT) using a computer touchscreen can produce similar after-effects to traditional PAT methods, but only if participants receive direct visual feedback on their pointing accuracy during the exposure phase.

In a study involving 81 healthy subjects and 7 brain-injured patients, indirect feedback methods (like icons on a screen) were ineffective, highlighting the importance of direct feedback for successful rehabilitation of visuospatial disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect versus direct feedback in computer-based Prism Adaptation Therapy. Wilms, I., Malá, H.[2010]

Prism adaptation treatment (PAT) is feasible for stroke survivors with multiple strokes and significantly improves spatial neglect compared to standard care, as shown by greater improvements in specific spatial function tests.

While both treatment and comparison groups improved in motor function, the treatment group's improvement was not statistically significant compared to the comparison group, indicating that PAT may be more effective for spatial than motor outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of using prism adaptation to treat motor and spatial dysfunction in stroke survivors with multiple incidents of stroke. Hreha, K., Gillen, G., Noce, N., et al.[2018]

In a follow-up study of nine participants with spatial neglect after stroke, 60% of those who received Prism Adaptation Treatment (PAT) still showed symptoms, indicating that while PAT may help, some individuals continue to experience neglect.

The study found that participants in the PAT group performed significantly better on the line bisection test compared to the standard care group, suggesting that PAT may have a beneficial effect on certain aspects of spatial neglect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A One-Year Follow-Up Study on Community Dwelling Multiple Stroke Survivors with Spatial Neglect. Hreha, K., Rich, T., Wong, J.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463461/

Prism Adaptation Treatment Improves Inpatient ... Patients with SN receiving PAT had better functional and cognitive outcomes, suggesting that integrating PAT into the standard of care is beneficial.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000101

Prism Adaptation Treatment for Right-Sided and Left- ... Objective. To compare the effectiveness of prism adaptation treatment (PAT) between patients with right- and left-sided spatial neglect (SN).

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22926312/

Prism adaptation for spatial neglect after stroke - PubMed - NIH In this article, we review 48 studies of a treatment of intense neuroscience interest: prism adaptation training. Due to its effects on spatial ...

4. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1539887/full

Does prism adaptation treatment reduce spatial neglect ... A total of 4,454 individuals were assessed using KF-NAP, 82% of them were stroke survivors, and 55% of the total sample had SN (CBS > 0) within the first week ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07157865

Comparing Prism Adaptation Training With and Without ... This study aims to find out if doing two treatments together-Prism Adaptation Therapy (PAT) and Transcutaneous Electrical Nerve Stimulation (TENS)-will help ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010528/

Prism Adaptation Treatment of Spatial Neglect This study examines the feasibility of Prism Adaptation Treatment (PAT) within an inpatient rehabilitation facility and the degree by which PAT improves ...

7. kesslerfoundation.org kesslerfoundation.org/researchcenter-stroke-rehabilitation-research/guide-spatial-neglect-healthcare-professionals

Guide to Spatial Neglect For Healthcare Professionals This guide for healthcare professionals discusses spatial neglect disorder caused by brain damage, with stroke as a common cause.

8. stoeltingco.com stoeltingco.com/Psychological/media/KF-PAT_Manual_Sample.pdf

Kessler Foundation Prism Adaptation Treatment KF-PAT® ... Research and product development work leading to the Kessler Foundation Prism Adaptation Treatment (KF‐PAT®) Portable. Kit and the KF‐PAT® Manual is supported ...

9. withpower.com withpower.com/trial/phase-perceptual-disorders-6-2021-eb40e

Prism Adaptation Therapy for Stroke-Related Perceptual ... Prism Adaptation Therapy (PAT) has been used safely in studies with both healthy individuals and stroke patients, with no reported safety concerns. It is a non- ...

10. kesslerfoundation.org kesslerfoundation.org/press-release/dosage-inpatient-prism-adaptation-treatment-spatial-neglect-predicts-outcomes-stroke

Dosage of inpatient prism adaptation treatment for spatial ... A team of stroke researchers found that the dosage of prism adaptation treatment correlated with improvement in post-stroke spatial neglect as well as in ...