Sensory NeglectNCT02680171
Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Stroke
A study testing Prism Goggles and Non-Shifting Goggles in people with Sensory Neglect and Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sensory Neglect, Stroke
- What is being tested?
- Prism Goggles and Non-Shifting Goggles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2018to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Experience mild to severe symptoms of neglect (as measured by the Sunnybrook Neglect Assessment Procedure and/or as determined based on clinical judgment of the treating team)
- Be willing to participate
- Be able to consent to participate
- Be medically stable
- Have normal or corrected to normal vision
- Be able to point to targets presented on a computer screen.
Who cannot join
- Other neurological disease (e.g., Multiple Sclerosis, Parkinsons disease)
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke
Spatial neglect is a common attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.
Read the detailed description
There is an unmet need for effective and feasible interventions for spatial neglect after right hemisphere stroke. Neglect is a frequent problem after stroke and makes it difficult for individuals to pay attention and notice information coming from the left side of their world. Thus, they often miss food on the left side of their plate, fail to wash or groom the left side of their face or body, or run into objects on the left side of the hall when walking or using their wheelchair. Neglect is associated with slower recovery, reduced independence, longer stays in rehabilitation and need for more resources when discharged. The investigators have developed a novel and simple computerized prism adaptation (PA) procedure for treating neglect, but the investigators don't know yet whether it is feasible and effective in a typical health care setting. Thus, the purpose of this project is to conduct a randomized, controlled clinical trial, comparing the PA method to a control intervention for the treatment of neglect. The investigators will measure feasibility of use in a clinical setting and effectiveness in terms of impairment (i.e., does PA improve neglect symptoms?), activities (i.e., does having PA improve independence in daily activities) and health care outcomes (i.e., does giving PA shorten length of stay and decrease the need for resources on discharge?). By treating neglect with PA, the overall aim is to improve the health care outcomes for those with neglect and to reduce need for extended hospital care.
A controlled, randomized design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA (experimental) or sham (control) conditions and complete 10, 30-minute intervention sessions over approximately two weeks. These intervention sessions will involve a novel and simple computerized prism adaptation, Peg-The-Mole (PTM). Outcome measures will be collected before and after each treatment, as well as at baseline, and a three month follow-up over the phone.
- Conditions
- Sensory Neglect, Stroke
- Being tested
- Prism Goggles, Non-Shifting Goggles
- Keywords
- Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism GogglesBehavioural
Patients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days.
Non-Shifting GogglesOther
Also called Control condition
Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.
| Study group | Role | What they receive |
|---|---|---|
| Prism adaptation treatment | Experimental | Prism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care. Receives: Behavioral: Prism Goggles |
| Sham prism adaptation treatment | Sham comparator | Non-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field. Receives: Other: Non-Shifting Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sunnybrook Neglect Assessment Procedure (SNAP)
Test of neglect severity
Measured: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Secondary outcomes (9)
Change in Johnny Shirt Visual Scanning Task
Test of neglect severity
Measured: Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)
Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Test of neglect severity
Measured: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Catherine Bergego Scale (CBS)
Scale of neglect impact on daily activities
Measured: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Halifax Neglect Severity Scale
Scale of neglect impact on daily activities
Measured: Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)
Change in Functional Independence Measure (FIM)
Measure of functional independence
Measured: Taken at baseline and at discharge up to 3 months
Frenchay Activities Index
Measure of functional independence
Measured: Taken at approximately 3 months post-discharge
Length of inpatient stay at the Rehabilitation Centre
Measure of hospital utilization
Measured: From admission to discharge up to 3 months
Discharge destination from Rehabilitation Centre
Measure of hospital utilization
Measured: At time of discharge up to 3 months from admission
Change in Proprioceptive and Visuo-motor pointing midline tasks
Used to assess prism adaptation after-effects
Measured: Taken from immediately before and at end of treatment session, about 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start6 Feb 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sensory NeglectStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Eskes, Nova Scotia Health Authority
- Investigators
- Gail A Eskes, PhD, Principal investigator, Nova Scotia Health Authority; Dalhousie UniversityRichard Braha, PhD, Principal investigator, Nova Scotia Health AuthorityAnne Sophie Champod, PhD, Study chair, Dalhousie University; Acadia UniversityJoy Boyce, BScOT, Study chair, Nova Scotia Health AuthorityMyrna King, BScOT, Study chair, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680171
- Sponsor's protocol ID
- TRICSpatialNeglect2016
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2016
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Champod AS, Taylor K, Eskes GA. Development of a new computerized prism adaptation procedure for visuo-spatial neglect. J Neurosci Methods. 2014 Sep 30;235:65-75. doi: 10.1016/j.jneumeth.2014.05.023. Epub 2014 Jun 19.
PubMed 24952321Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness Study of Implementing Prism Adaptation as a Treatment for Spatial Neglect After Right Hemisphere Stroke
- ClinicalTrials.gov ID
- NCT02680171
- Acronym / sponsor ID
- TRICSpatialNeglect2016
- Conditions
- Sensory Neglect, Stroke
- Keywords
- Cognitive Rehabilitation, Prism Adaptation, Stroke, Spatial Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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 attention disorder after right hemisphere stroke and is associated with decreased independence and quality of life. Despite its high prevalence in the stroke population, there is currently no standard of care for the treatment of neglect. Prism adaptation (PA) is a promising rehabilitation technique, however incorporation into clinical care has been limited likely due to the lack of standardized procedures. The investigators have developed a computerized PA technique designed to better engage patients and assist clinicians. In this study the investigators aim to evaluate the feasibility and effectiveness of the computerized PA procedure in a typical health care setting, with the hypothesis that the PA procedure will improve patient's neglect symptoms.
Detailed description
There is an unmet need for effective and feasible interventions for spatial neglect after right hemisphere stroke. Neglect is a frequent problem after stroke and makes it difficult for individuals to pay attention and notice information coming from the left side of their world. Thus, they often miss food on the left side of their plate, fail to wash or groom the left side of their face or body, or run into objects on the left side of the hall when walking or using their wheelchair. Neglect is associated with slower recovery, reduced independence, longer stays in rehabilitation and need for more resources when discharged. The investigators have developed a novel and simple computerized prism adaptation (PA) procedure for treating neglect, but the investigators don't know yet whether it is feasible and effective in a typical health care setting. Thus, the purpose of this project is to conduct a randomized, controlled clinical trial, comparing the PA method to a control intervention for the treatment of neglect. The investigators will measure feasibility of use in a clinical setting and effectiveness in terms of impairment (i.e., does PA improve neglect symptoms?), activities (i.e., does having PA improve independence in daily activities) and health care outcomes (i.e., does giving PA shorten length of stay and decrease the need for resources on discharge?). By treating neglect with PA, the overall aim is to improve the health care outcomes for those with neglect and to reduce need for extended hospital care.
A controlled, randomized design will be used in the present study. Patients will be randomly assigned (with stratification related to neglect severity) to PA (experimental) or sham (control) conditions and complete 10, 30-minute intervention sessions over approximately two weeks. These intervention sessions will involve a novel and simple computerized prism adaptation, Peg-The-Mole (PTM). Outcome measures will be collected before and after each treatment, as well as at baseline, and a three month follow-up over the phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prism adaptation treatment | Experimental | Behavioral: Prism GogglesPrism Goggles with ten-degree rightward deviating prism lenses will be used to implement prism adaptation treatment, in addition to standard care. |
| Sham prism adaptation treatment | Sham comparator | Other: Non-Shifting GogglesNon-Shifting Goggles (sham) will be worn by patients in the control condition. These goggles do not shift the patients visual field. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Experience mild to severe symptoms of neglect (as measured by the Sunnybrook Neglect Assessment Procedure and/or as determined based on clinical judgment of the treating team)
- Be willing to participate
- Be able to consent to participate
- Be medically stable
- Have normal or corrected to normal vision
Key exclusion criteria (2 listed)
- Other neurological disease (e.g., Multiple Sclerosis, Parkinsons disease)
- Dementia
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 GogglesPatients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days. | Behavioural | Prism adaptation treatment |
| Non-Shifting GogglesAlso: Control conditionNon-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation. | Other | Sham prism adaptation treatment |
Primary outcome
Change in Sunnybrook Neglect Assessment Procedure (SNAP)
Time frame: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)
Test of neglect severity
9 secondary outcomes
Change in Johnny Shirt Visual Scanning Task
Time frame: Taken at baseline, after five intervention sessions are completed (approximately 1 week post-treatment start), and after the intervention (approximately two weeks post-treatment start)
Change in Behavioural Inattention Test - Behaviour subtests (BIT-B)
Time frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Catherine Bergego Scale (CBS)
Time frame: Taken at baseline and after the intervention (approximately two weeks post-treatment start)
Change in Halifax Neglect Severity Scale
Time frame: Taken after the intervention (approximately two weeks post-treatment start) and at follow-up (approximately 3 months post-discharge from the Nova Scotia Rehabilitation and Arthritis Centre)
Change in Functional Independence Measure (FIM)
Time frame: Taken at baseline and at discharge up to 3 months
Frenchay Activities Index
Time frame: Taken at approximately 3 months post-discharge
Length of inpatient stay at the Rehabilitation Centre
Time frame: From admission to discharge up to 3 months
Discharge destination from Rehabilitation Centre
Time frame: At time of discharge up to 3 months from admission
Change in Proprioceptive and Visuo-motor pointing midline tasks
Time frame: Taken from immediately before and at end of treatment session, about 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 24952321Champod AS, Taylor K, Eskes GA. Development of a new computerized prism adaptation procedure for visuo-spatial neglect. J Neurosci Methods. 2014 Sep 30;235:65-75. doi: 10.1016/j.jneumeth.2014.05.023. Epub 2014 Jun 19.
- Derived from this study: PubMed 34196963Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
- Individual participant dataSharing planned: No
Related trials for Sensory Neglect
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Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)
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Neglect, Sensory, Neglect, Hemispatial
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. This study is not recruiting at the moment.
Gail A Eskes, PhD principal investigator
Nova Scotia Health Authority; Dalhousie University
Richard Braha, PhD principal investigator
Nova Scotia Health Authority
Anne Sophie Champod, PhD study chair
Dalhousie University; Acadia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism Goggles and Non-Shifting Goggles in people with Sensory Neglect and Stroke, run by Nova Scotia Health Authority at 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sunnybrook Neglect Assessment Procedure (SNAP) (time frame: Taken at baseline and after the intervention has been completed (approximately two weeks post-treatment start)). 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 NCT02680171, which also lists 2 linked publications.
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 22 Jun 2023.