Prism Adaptation for Spatial Neglect

(EMPATH Trial)

Recruiting at 3 trial locations

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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new game-like treatment for spatial neglect, a condition often seen after a stroke that causes difficulty in noticing things on the left side. The treatment involves wearing special prism goggles (Prism Adaptation - 15-degree and 5-degree prism goggles) that might help improve symptoms. Researchers aim to determine if people can use this treatment at home and if it reduces the impact of spatial neglect on daily activities. The trial seeks participants who have had a right hemisphere stroke, experience neglect symptoms, and live near Halifax. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with spatial neglect.

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 prior data suggests that this prism adaptation treatment is safe for stroke patients with spatial neglect?

Research has shown that prism adaptation, involving special goggles, has been studied in stroke patients with spatial neglect. These studies have not identified any major safety concerns. Patients generally tolerate the treatment well, participating in short daily sessions without significant issues.

Different studies have used both 15-degree and 5-degree prism goggles to address spatial neglect. Neither type has been associated with major side effects, suggesting that the treatment is generally safe for improving patients' ability to notice and respond to stimuli on their neglected side. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prism adaptation for spatial neglect because it offers a unique approach compared to traditional therapies like occupational therapy or visual scanning training. Unlike these standard treatments, prism adaptation uses specialized goggles with prism lenses to shift the visual field, helping the brain rewire and improve spatial awareness. This technique taps into the brain's natural adaptability, potentially providing quicker and more lasting improvements in spatial neglect symptoms. The use of 15-degree and 5-degree prism goggles allows for a controlled study of their effects, offering insights into how different levels of prism deviation might impact recovery.

What evidence suggests that prism adaptation is effective for spatial neglect?

Research has shown that prism adaptation (PA) can improve symptoms of spatial neglect, a condition where stroke patients struggle to notice things on one side. One study found that patients using PA performed much better on attention tests than those who did not. However, some results are mixed, with other studies not showing immediate benefits. Despite these mixed findings, PA remains of interest because it might help patients become more independent in daily activities. In this trial, participants will receive either the experimental PA treatment using 15-degree prism goggles or a placebo control using 5-degree prism goggles. The game-like PA treatment being tested could make it easier for people to use this therapy at home. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

Experience mild to severe symptoms of neglect

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3566983/

Prism adaptation for spatial neglect after stroke In this article, we review 48 studies of a treatment of intense neuroscience interest: prism adaptation training.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11835888/

Does prism adaptation treatment reduce spatial neglect and ... The potential of using prism adaptation for treating spatial neglect (SN) was questioned when recent meta-analyses found inconsistent evidence.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0028393223001008

No short-term treatment effect of prism adaptation for ... We found no evidence of short-term effects of prism adaptation for spatial neglect. The outcomes are robust to removal of outliers and studies with high risk- ...

4. journals.lww.com journals.lww.com/ajpmr/fulltext/2021/06000/effects_of_prism_adaptation_for_unilateral_spatial.10.aspx

Effects of Prism Adaptation for Unilateral Spatial Neglect... According to meta-analysis results, prism adaptation group scored significantly higher than control group in improving Behavioral Inattention Test (mean ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05595668

Engaging Mobile Prism Adaptation Treatment at Home Patients will be randomly assigned (with stratification related to neglect severity) to PA with the use of 15-degree rightward deviating goggles (experimental ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4415396/

Prism adaptation and spatial neglect: the need for dose- ... Prism adaptation is a promising treatment for neglect that involves brief, daily visuo-motor training sessions while wearing optical prisms.

7. withpower.com withpower.com/trial/phase-1-spatial-neglect-10-2022-895a1

Prism Adaptation for Spatial Neglect (EMPATH Trial) Prism adaptation has been tested in various studies, including with stroke patients, and no significant safety concerns have been reported. It involves wearing ...

8. mdpi.com mdpi.com/2076-3425/11/11/1488

Prism Adaptation and Optokinetic Stimulation Comparison ... The aim of this study is to compare the effectiveness of these two methods in a group of neglect patients using a crossover design.

9. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42542

Short-term effect of prism adaptation treatment on severity ... Objective: This work aimed to investigate the effects of prism adaptation on unilateral spatial neglect following right hemispheric stroke.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999306012639

Use of Fresnel Prism Glasses to Treat Stroke Patients With ... Prism adaptation training shows promise as a new treatment to supplement current strategies for the clinical management of hemispatial neglect after stroke.