Prism Adaptation Therapy for Stroke Rehabilitation

Recruiting at 2 trial locations

Overseen By Anna M Barrett, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Multiple sclerosis, Alzheimer, left brain stroke, 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: 12

Duration: 2 weeks

244 Participants Needed

Trial Summary

What is the purpose of this trial?

After a right brain stroke, \>50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Spatial neglect prevents them from functioning independently, and their needs in the hospital and at home are greatly increased. An effective treatment for spatial neglect is 10 days of visuomotor training while wearing optical prisms (PAT), however many clinicians \[fail to diagnose spatial neglect and use this approach. In this study, the investigators will develop a brain scanning test that could objectively identify the Veterans with spatial neglect after stroke who are the best candidates to receive PAT and recover their ability to function. When the research is complete, the investigators expect that brain scans done in the hospital can guide the team to refer Veterans to PAT rehabilitation: improving daily life function\] and quality of life.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prism Adaptation Therapy for stroke rehabilitation?

Research shows that Prism Adaptation Therapy (PAT) can improve spatial neglect and rehabilitation outcomes in stroke patients, especially when more sessions are provided. Patients receiving more frequent PAT sessions showed better improvement in spatial neglect and overall rehabilitation progress. ^{1 2 3 4 5}

Is Prism Adaptation Therapy safe for humans?

Prism Adaptation Therapy (PAT) has been used in studies with stroke survivors and healthy subjects, and no specific safety concerns have been reported in these studies. It involves wearing prism goggles and performing tasks, which appears to be generally safe for participants. ^{1 3 5 6 7}

How is Prism Adaptation Therapy different from other treatments for stroke rehabilitation?

Prism Adaptation Therapy (PAT) is unique because it uses prismatic lenses to shift the visual field, helping to reorganize sensorimotor coordination. This approach is particularly effective for improving spatial and motor functions in stroke patients, especially those with spatial neglect, by emphasizing an 'ascending' strategy that focuses on enhancing the brain's natural adaptation processes rather than just compensating for deficits. ^{1 4 6 8 9}

Research Team

Anna M. Barrett, MD

Principal Investigator

VA Central Western Massachusetts Healthcare System, Leeds, MA

Eligibility Criteria

This trial is for Veterans over 18 who've had their first right brain stroke within the last 1-4 months. They must be able to sit up, have vision better than 20/50 in both eyes, and give informed consent. It's not for those with other neurological disorders like Alzheimer's, previous left brain strokes or significant prior strokes visible on scans.

Inclusion Criteria

I can sit up, see clearly with both eyes, and point to objects.

Can give informed consent to participate

I was diagnosed with a right brain stroke 1-4 months ago.

Exclusion Criteria

You have poor vision, seeing less clearly than most people.

I have a chronic neurological condition like MS or Alzheimer's.

I have had a stroke on the left side of my brain or scans show I've had strokes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 days of visuomotor training while wearing optical prisms (PAT) to treat spatial neglect

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for improvements in functional independence and spatial neglect severity

5 weeks

2 visits (in-person)

Treatment Details

Interventions

• Prism Adaptation Therapy

Trial Overview The study tests Prism Adaptation Therapy (PAT) as a rehabilitation method for spatial neglect after a right brain stroke. The therapy involves visuomotor training while wearing optical prisms over a period of ten days. Researchers aim to develop a brain scan test to identify candidates for PAT.

Participant Groups

Group I: No spatial neglect Active Control 1 Intervention

People without spatial neglect symptoms will not receive an intervention for spatial neglect.

Group II: Prism adaptation Therapy Active Control 1 Intervention

People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms.

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?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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 study of 520 patients receiving prism adaptation treatment (PAT) for spatial neglect (SN), more sessions of PAT were associated with greater improvement in SN, particularly in those with moderate-to-severe neglect.

The frequency of PAT sessions also positively influenced rehabilitation outcomes, with patients completing 8 or more sessions showing better SN improvement, highlighting the importance of treatment dosage in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Prism Adaptation Treatment on Spatial Neglect and Rehabilitation Outcome: Dosage Matters. Chen, P., Hreha, K., Gonzalez-Snyder, C., 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 therapy, which uses prismatic goggles to help patients point to visual targets, has shown significant improvements in treating visuo-spatial disorders like unilateral neglect, suggesting a shift from traditional rehabilitation methods that focus on patients' deficits.

This ascending approach to rehabilitation emphasizes the importance of visuo-manual adaptation and has the potential to enhance not only visual and motor skills but also higher cognitive functions, indicating a need for a theoretical reevaluation of neurorehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prism adaptation in the rehabilitation of patients with visuo-spatial cognitive disorders. Pisella, L., Rode, G., Farnè, A., et al.[2013]

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]

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 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 involving 29 stroke patients with left visual neglect, prismatic lenses that only deviated the visual field by 5 degrees did not show any significant therapeutic effect compared to placebo lenses.

The observed improvements in both groups were likely due to the pointing exercises rather than the prismatic lenses, suggesting that effective treatment may require stronger lenses (at least 20 prism diopters) to create a meaningful impact on neglect rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of prismatic lenses in the rehabilitation of neglect patients. A randomized controlled trial. Mancuso, M., Pacini, M., Gemignani, P., et al.[2016]

References

1. England 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. [2018]

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

Impacts of Prism Adaptation Treatment on Spatial Neglect and Rehabilitation Outcome: Dosage Matters. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Indirect versus direct feedback in computer-based Prism Adaptation Therapy. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Prism adaptation in the rehabilitation of patients with visuo-spatial cognitive disorders. [2013]

5. England pubmed.ncbi.nlm.nih.gov

A One-Year Follow-Up Study on Community Dwelling Multiple Stroke Survivors with Spatial Neglect. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Prism Adaptation Treatment Predicts Improved Rehabilitation Responses in Stroke Patients with Spatial Neglect. [2022]

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

Prism Adaptation Treatment for Right-Sided and Left-Sided Spatial Neglect: A Retrospective Case-Matched Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Prisms for pain. Can visuo-motor rehabilitation strategies alleviate chronic pain? [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Clinical application of prismatic lenses in the rehabilitation of neglect patients. A randomized controlled trial. [2016]