Spatial NeglectEMPATHNCT05595668
Engaging Mobile Prism Adaptation Treatment at Home
A study testing Prism Adaptation - 15-degree prism goggles and Prism Adaptation - 5-degree prism goggles in people with Spatial Neglect, run by Nova Scotia Health Authority at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spatial Neglect
- What is being tested?
- Prism Adaptation - 15-degree prism goggles and Prism Adaptation - 5-degree prism goggles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesCanada
- Study dates
- 15 Sep 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have experienced a right hemisphere stroke (confirmed by a clinician)
- Experience mild to severe symptoms of neglect
- Be willing and able to consent to participate
- Be medically stable
- Have self-reported normal to corrected-to-normal vision
- Be able to point to targets presented on a computer screen
- Live within a two-hour radius of Halifax
Who cannot join
- Other existing neurological disorders (e.g., dementia, multiple sclerosis, epilepsy).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Nova Scotia Health Early Supported Stroke Discharge Team
Bedford, Nova Scotia, B3H 4K4
Joy Boyce, 902-473-7361, joy.boyce@nshealth.ca
- Not yet recruiting
Nova Scotia Rehabilitation and Arthritis Centre (NSRAC)
Halifax, Nova Scotia, B2T 1L7
Anne Sophie Champod, MD
Anne Sophie Champod, MD
- Recruiting
Nova Scotia Rehabilitation and Arthritis Centre
Halifax, Nova Scotia, B3H 4K4
Matthew Miller, 902-473-7361, MatthewD.Miller@nshealth.ca
- Recruiting
Valley Regional Hospital
Kentville, Nova Scotia, B4N 5E3
Kyla Harris, 902-698-3263, kyla.harris2@nshealth.ca
About this study
Official title: Feasibility and Effectiveness of a New Computerized Treatment Protocol for Spatial Neglect Post Stroke During Inpatient and Outpatient Rehabilitation
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.
Read the detailed description
Spatial neglect is a common debilitating cognitive syndrome after stroke which is characterized by an inability to pay attention or respond to the left side of space. Thus, individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming Individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming which lead to increased assistance needed from a caretaker. Although this syndrome has been linked to poor rehabilitation outcomes and reduced independence in everyday life, there is currently an unmet need for an effective and feasible intervention for the treatment of spatial neglect. The investigators have developed and validated a novel, simple, and gamified computerized prism adaptation (PA) procedure for the treatment of spatial neglect. The goal of the present study is to extend this treatment to iPad administration and to test whether the protocol is feasible and effective in a typical inpatient stroke health care setting and in the home setting. Thus, the purpose of this project is to conduct a randomized, controlled, multi-site clinical trial, comparing the PA method to a placebo control intervention for the treatment of spatial neglect. The investigators will measure short- and longer-term effectiveness in terms of impairment (i.e., does PA improve neglect symptoms over time), impact on activities of daily living (i.e., foes PA improve independence in daily activities). Feasibility will be measured by overall treatment compliance and patient feedback on usability. This novel PA procedure has the potential to improve patient recovery and quality of life after stroke due to its gamified and portable features that promote treatment accessibility and adherence. The results will help determine if the treatment can be used successfully in inpatient and outpatient settings and who is likely to benefit.
A longitudinal, double-blind, randomized controlled design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA with the use of 15-degree rightward deviating goggles (experimental condition) or PA with the use of 5-degree deviating goggles (placebo control condition). Participants will complete 10, 15-minute training sessions over approximately two weeks. These intervention sessions will involve using a novel and game-like iPad-administered PA procedure called Peg-the-Mole (PTM). Participants will complete the intervention sessions in an inpatient setting or in their homes, depending on their predicted length of hospital stay. A hybrid model will be adopted if a patient is discharged before the intervention is complete. Outcome measures will be collected immediately before, immediately after, and one-month post-treatment and compared between conditions.
- Conditions
- Spatial Neglect
- Being tested
- Prism Adaptation - 15-degree prism goggles, Prism Adaptation - 5-degree prism goggles
- Keywords
- Spatial Neglect, Prism Adaptation, Rehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism Adaptation - 15-degree prism gogglesBehavioural
Patients in the experimental condition will wear prism goggles while completing an iPad-administered aiming task. The prisms will shift the patients' vision 15 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out for ten sessions for 15 minutes a day, over the span of two weeks.
Prism Adaptation - 5-degree prism gogglesOther
Also called Control condition
5-degree goggles are worn instead of the 15-degree prism goggles, while completing the same tasks as those assigned to the 15-degree condition.
| Study group | Role | What they receive |
|---|---|---|
| Prism adaptation treatment | Experimental | Prism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care. Receives: Behavioral: Prism Adaptation - 15-degree prism goggles |
| Placebo control prism adaptation treatment | Placebo comparator | Prism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology. Receives: Other: Prism Adaptation - 5-degree prism goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of neglect severity 1
Change in Behavioural Inattention Test - All conventional subtests (BIT-C)
Measured: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Test of neglect severity 2
Change in after-effects measured by a modified proprioceptive-and-visual straight-ahead outcome task without the use of an occlusion board
Measured: measured immediately before and immediately after each intervention session
Test of neglect severity 3
Change in Behavioural Inattention Test - Select behavioural subtests (BIT-B): Article Reading, Menu Reading, and Picture Scanning
Measured: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Test of neglect impact on daily activities
Change in an Eschenbeck Standardized Activities of Daily Living task: Filling out a Form
Measured: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Scale of neglect impact on daily activities
Change in Halifax Neglect Impact Scale
Measured: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Measure of feasibility Measure of feasibility
Treatment compliance with the intervention schedule daily
Measured: logged immediately following each intervention session through training logs
Measure of feasibility 2
Patient feedback exit questionnaire
Measured: collected immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 Sep 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sophie Champod, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595668
- Sponsor's protocol ID
- EMPATH
- Acronym
- EMPATH
- Status last verified
- Jul 2025
- First submitted
- 14 Oct 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacPhee C, Eskes G, Mackinnon SP, Champod AS. EMPATH protocol: Randomized, double-blind trial of an Engaging and Mobile Prism Adaptation Treatment for spatial neglect in Home and rehabilitation settings. PLoS One. 2026 Aug 17;21(8):e0356055. doi: 10.1371/journal.pone.0356055. eCollection 2026.
PubMed 42607058
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a New Computerized Treatment Protocol for Spatial Neglect Post Stroke During Inpatient and Outpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT05595668
- Acronym / sponsor ID
- EMPATH / EMPATH
- Conditions
- Spatial Neglect
- Keywords
- Spatial Neglect, Prism Adaptation, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spatial neglect is a common debilitating cognitive syndrome after stroke which is characterized by an inability to pay attention or respond to the left side of space. Thus, individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming Individuals who face this condition often experience difficulties with mobility, reading, and self-care activities such as eating, dressing, and grooming which lead to increased assistance needed from a caretaker. Although this syndrome has been linked to poor rehabilitation outcomes and reduced independence in everyday life, there is currently an unmet need for an effective and feasible intervention for the treatment of spatial neglect. The investigators have developed and validated a novel, simple, and gamified computerized prism adaptation (PA) procedure for the treatment of spatial neglect. The goal of the present study is to extend this treatment to iPad administration and to test whether the protocol is feasible and effective in a typical inpatient stroke health care setting and in the home setting. Thus, the purpose of this project is to conduct a randomized, controlled, multi-site clinical trial, comparing the PA method to a placebo control intervention for the treatment of spatial neglect. The investigators will measure short- and longer-term effectiveness in terms of impairment (i.e., does PA improve neglect symptoms over time), impact on activities of daily living (i.e., foes PA improve independence in daily activities). Feasibility will be measured by overall treatment compliance and patient feedback on usability. This novel PA procedure has the potential to improve patient recovery and quality of life after stroke due to its gamified and portable features that promote treatment accessibility and adherence. The results will help determine if the treatment can be used successfully in inpatient and outpatient settings and who is likely to benefit.
A longitudinal, double-blind, randomized controlled design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA with the use of 15-degree rightward deviating goggles (experimental condition) or PA with the use of 5-degree deviating goggles (placebo control condition). Participants will complete 10, 15-minute training sessions over approximately two weeks. These intervention sessions will involve using a novel and game-like iPad-administered PA procedure called Peg-the-Mole (PTM). Participants will complete the intervention sessions in an inpatient setting or in their homes, depending on their predicted length of hospital stay. A hybrid model will be adopted if a patient is discharged before the intervention is complete. Outcome measures will be collected immediately before, immediately after, and one-month post-treatment and compared between conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism adaptation treatment | Experimental | Behavioral: Prism Adaptation - 15-degree prism gogglesPrism Goggles with 15-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care. |
| Placebo control prism adaptation treatment | Placebo comparator | Other: Prism Adaptation - 5-degree prism gogglesPrism goggles with 5-degree rightward deviating prism lenses will be used to maintain the double-blind methodology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have experienced a right hemisphere stroke (confirmed by a clinician)
- Experience mild to severe symptoms of neglect
- Be willing and able to consent to participate
- Be medically stable
- Have self-reported normal to corrected-to-normal vision
Key exclusion criteria (1 listed)
- Other existing neurological disorders (e.g., dementia, multiple sclerosis, epilepsy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism Adaptation - 15-degree prism gogglesPatients in the experimental condition will wear prism goggles while completing an iPad-administered aiming task. The prisms will shift the patients' vision 15 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out for ten sessions for 15 minutes a day, over the span of two weeks. | Behavioural | Prism adaptation treatment |
| Prism Adaptation - 5-degree prism gogglesAlso: Control condition5-degree goggles are worn instead of the 15-degree prism goggles, while completing the same tasks as those assigned to the 15-degree condition. | Other | Placebo control prism adaptation treatment |
Primary outcome
Test of neglect severity 1
Time frame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Change in Behavioural Inattention Test - All conventional subtests (BIT-C)
Test of neglect severity 2
Time frame: measured immediately before and immediately after each intervention session
Change in after-effects measured by a modified proprioceptive-and-visual straight-ahead outcome task without the use of an occlusion board
Test of neglect severity 3
Time frame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Change in Behavioural Inattention Test - Select behavioural subtests (BIT-B): Article Reading, Menu Reading, and Picture Scanning
Test of neglect impact on daily activities
Time frame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Change in an Eschenbeck Standardized Activities of Daily Living task: Filling out a Form
Scale of neglect impact on daily activities
Time frame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention
Change in Halifax Neglect Impact Scale
Measure of feasibility Measure of feasibility
Time frame: logged immediately following each intervention session through training logs
Treatment compliance with the intervention schedule daily
Measure of feasibility 2
Time frame: collected immediately after the intervention
Patient feedback exit questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 42607058MacPhee C, Eskes G, Mackinnon SP, Champod AS. EMPATH protocol: Randomized, double-blind trial of an Engaging and Mobile Prism Adaptation Treatment for spatial neglect in Home and rehabilitation settings. PLoS One. 2026 Aug 17;21(8):e0356055. doi: 10.1371/journal.pone.0356055. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism Adaptation - 15-degree prism goggles and Prism Adaptation - 5-degree prism goggles in people with Spatial Neglect, run by Nova Scotia Health Authority at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Sophie Champod, PhD (9028176871, anne.champod@acadiau.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of neglect severity 1 (time frame: taken at baseline (immediately before the intervention), immediately after the intervention, and one month after the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.