244 Participants Needed

Prism Adaptation Therapy for Stroke Rehabilitation

Recruiting at 2 trial locations
LS
AM
Overseen ByAnna M Barrett, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping Veterans who have experienced a right brain stroke and now struggle with spatial neglect, which causes difficulty in noticing things on their left side. Researchers are testing Prism Adaptation Therapy (PAT), a treatment using special glasses to improve movement and awareness on the left side. The goal is to develop a brain scan test to identify those who will benefit most from PAT, potentially enhancing their independence in daily activities. This trial suits individuals who had a right brain stroke 1-4 months ago, can sit up, see well enough to point at objects, and are free of other serious brain disorders. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance treatment options for future 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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Prism Adaptation Therapy is safe for stroke rehabilitation?

Research has shown that Prism Adaptation Therapy (PAT) is a well-researched treatment for spatial neglect, a condition often occurring after a stroke. Patients who received PAT improved in performing daily tasks and thinking more clearly, indicating that PAT is both effective and safe.

Studies have found that patients easily handle PAT, with no serious side effects reported. Stroke rehabilitation guidelines even recommend it for treating spatial neglect. This treatment involves wearing special glasses with prisms during training, which helps improve awareness of the left side.

Overall, past research supports the safety of PAT for those recovering from a stroke. For those considering joining a trial using PAT, existing evidence suggests it is a safe option.12345

Why are researchers excited about this trial?

Researchers are excited about Prism Adaptation Therapy for stroke rehabilitation because it offers a unique approach for addressing spatial neglect, a common post-stroke condition. Unlike traditional therapies that often focus on repetitive exercises to improve motor skills, this therapy uses special glasses with prism lenses to shift visual perception, helping the brain recalibrate its spatial awareness. This method directly targets the brain's ability to process spatial information, potentially offering quicker and more effective symptom reduction. By focusing on the underlying brain processes rather than just physical symptoms, Prism Adaptation Therapy could revolutionize how we approach rehabilitation for stroke patients with spatial neglect.

What evidence suggests that Prism Adaptation Therapy is effective for spatial neglect?

Research has shown that Prism Adaptation Therapy (PAT), which participants with spatial neglect in this trial will receive, can help treat spatial neglect after a stroke. One study found that patients who received PAT improved in performing daily activities. Another study noted that more PAT sessions can lead to better recovery. However, some research presents mixed results regarding its effectiveness. Despite this, many experts believe PAT can help reduce symptoms of spatial neglect, especially for those who have trouble aiming.24678

Who Is on the Research Team?

AM

Anna M. Barrett, MD

Principal Investigator

VA Central Western Massachusetts Healthcare System, Leeds, MA

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 1 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: No spatial neglectActive Control1 Intervention
Group II: Prism adaptation TherapyActive Control1 Intervention

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

🇺🇸
Approved in United States as Prism Adaptation Therapy for:

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Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

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.
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 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.
Impacts of Prism Adaptation Treatment on Spatial Neglect and Rehabilitation Outcome: Dosage Matters.Chen, P., Hreha, K., Gonzalez-Snyder, C., 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.
Clinical application of prismatic lenses in the rehabilitation of neglect patients. A randomized controlled trial.Mancuso, M., Pacini, M., Gemignani, P., et al.[2016]

Citations

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.
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).
Dosage of inpatient prism adaptation treatment for spatial ...Number and frequency of prism adaptation treatment sessions correlate with improvement in spatial neglect and rehabilitation outcome.
Does prism adaptation treatment reduce spatial neglect ...The potential of using prism adaptation for treating spatial neglect (SN) was questioned when recent meta-analyses found inconsistent evidence.
Guide to Spatial Neglect For Healthcare ProfessionalsThis guide for healthcare professionals discusses spatial neglect disorder caused by brain damage, with stroke as a common cause.
Kessler Foundation Prism Adaptation Treatment (KF-PAT) ...Kessler Foundation Prism Adaptation Therapy - A complete course of treatment for spatial neglect, a common complication of stroke that hinders recovery.
Prism Adaptation Treatment of Spatial NeglectThis study examines the feasibility of Prism Adaptation Treatment (PAT) within an inpatient rehabilitation facility and the degree by which PAT improves ...
Kessler Foundation Prism Adaptation Treatment KF-PAT® ...Evidence-based treatment. Prism adaptation treatment is recommended for spatial neglect in the stroke rehabilitation practice guidelines published in 2016 by ...
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