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?

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.

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.12345

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.13678

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.34589

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:

Find a Clinic Near You

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

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

Citations

The feasibility and effectiveness of using prism adaptation to treat motor and spatial dysfunction in stroke survivors with multiple incidents of stroke. [2018]
Impacts of Prism Adaptation Treatment on Spatial Neglect and Rehabilitation Outcome: Dosage Matters. [2022]
Indirect versus direct feedback in computer-based Prism Adaptation Therapy. [2010]
Prism adaptation in the rehabilitation of patients with visuo-spatial cognitive disorders. [2013]
A One-Year Follow-Up Study on Community Dwelling Multiple Stroke Survivors with Spatial Neglect. [2020]
Prism Adaptation Treatment Predicts Improved Rehabilitation Responses in Stroke Patients with Spatial Neglect. [2022]
Prism Adaptation Treatment for Right-Sided and Left-Sided Spatial Neglect: A Retrospective Case-Matched Study. [2023]
Prisms for pain. Can visuo-motor rehabilitation strategies alleviate chronic pain? [2022]
Clinical application of prismatic lenses in the rehabilitation of neglect patients. A randomized controlled trial. [2016]
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