Prism Adaptation for Spatial Neglect

(EMPATH Trial)

Overseen By Anne Sophie Champod, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Dementia, Multiple sclerosis, Epilepsy, others

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Spatial neglect is a common disorder after stroke which leads to problems with noticing or responding to information from the left side of the body or space. This condition has been linked to reduced independence in a wide range of daily life activities including eating, dressing, and mobility. Despite its high prevalence in stroke patients, there is currently no standard of care for spatial neglect. Prism adaptation (PA) is a promising treatment, however, there are limitations to using PA in standard clinical care as it requires daily exposure for at least two weeks, yet access to equipment and supervision is limited. To solve this problem, the investigators have developed a new game-like PA treatment (Peg-the-Mole, PTM) that can be used at home without the need for daily in person therapist set-up and supervision. In this study the investigators aim to evaluate the feasibility and effectiveness of the gamified and portable PA procedure in an inpatient and home setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Prism Adaptation for Spatial Neglect?

Research shows that prism adaptation, which involves wearing special goggles that shift the visual field, can help improve symptoms of spatial neglect, a condition often seen after brain damage or stroke. Studies have found that this treatment can lead to long-term improvements in visual search, eye movements, and everyday functions, even in patients with chronic neglect. ^{1 2 3 4 5}

Is prism adaptation generally safe for humans?

Prism adaptation has been tested in various studies, including with stroke patients, and no significant safety concerns have been reported. It involves wearing special goggles for short training sessions, and participants have shown high compliance with the treatment. ^{1 2 4 6 7}

How does prism adaptation treatment for spatial neglect differ from other treatments?

Prism adaptation treatment for spatial neglect is unique because it involves wearing special goggles that shift the visual field, helping to retrain the brain's perception and improve symptoms like visual search and motor function. Unlike other treatments, it can have long-lasting effects after just a few sessions and may even improve cognitive functions related to spatial awareness. ^{1 3 4 5 6}

Eligibility Criteria

This trial is for individuals who are stable after a right hemisphere stroke and have symptoms of spatial neglect, affecting their ability to notice or respond to the left side. Participants must be able to consent, have normal vision (with correction if needed), point at computer screen targets, and live within two hours of Halifax.

Inclusion Criteria

Have self-reported normal to corrected-to-normal vision

Be medically stable

I had a stroke that affected the right side of my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10, 15-minute training sessions using the Peg-the-Mole (PTM) procedure over approximately two weeks, either in an inpatient setting or at home.

2 weeks

10 sessions (in-person or at home)

Follow-up

Participants are monitored for changes in neglect severity and impact on daily activities immediately after treatment and one month post-treatment.

4 weeks

Treatment Details

Interventions

• Prism Adaptation - 15-degree prism goggles
• Prism Adaptation - 5-degree prism goggles

Trial Overview The study tests a new home-based game-like treatment using prism goggles that shift vision degrees to the right. It aims to improve independence in daily activities by reducing spatial neglect symptoms without needing daily therapist supervision.

Participant Groups

Group I: Prism adaptation treatment Experimental Treatment 1 Intervention

Prism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care.

Group II: Placebo control prism adaptation treatment Placebo Group 1 Intervention

Prism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

References

1. England pubmed.ncbi.nlm.nih.gov

Finding Wally: prism adaptation improves visual search in chronic neglect. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Prism adaptation for spatial neglect after stroke: translational practice gaps. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Wheel-chair driving improvement following visuo-manual prism adaptation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a new computerized prism adaptation procedure for visuo-spatial neglect. [2022]

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

Rehabilitation of spatial neglect by prism adaptation: a peculiar expansion of sensorimotor after-effects to spatial cognition. [2013]

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

Prism adaptation and spatial neglect: the need for dose-finding studies. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A single blinded randomised controlled pilot trial of prism adaptation for improving self-care in stroke patients with neglect. [2016]