Hemispatial NeglectNCT02608190
Rehabilitating Unilateral Neglect Using Spatial Working Memory Training
A study testing Working memory training in people with Hemispatial Neglect, run by University of Waterloo at 1 site in Canada.
Trial summary
Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right hemisphere of the brain and the parietal cortex in particular, is common and results in a disorder known as 'neglect' in 40% to 95% of patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke presence of neglect symptoms
Who cannot join
- any other neurological or psychiatric syndrome
- any incapacity to perform the tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Working Memory Training to Rehabilitate Unilateral Visual Neglect
Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right hemisphere of the brain and the parietal cortex in particular, is common and results in a disorder known as 'neglect' in 40% to 95% of patients. These patients fail to attend to or respond to events occurring in left space; the disorder is devastating for the patient and their caregivers with the patient becoming dependent on assistance for most activities of daily life (ADLs).
The project will implement two visual working memory (VWM) training programs to explore the influence of VWM training on neglect symptoms as well as activities of daily life.
Read more
Hypothesis: It is hypothesised that SWM training protocols will lead to improvements of neglect symptoms as well as improvement in ADLs.
The project will develop a novel rehabilitation strategy for treating the neglect syndrome.
Evidence from research in healthy participants employing video games to improve cognition along with research using working memory training protocols showing a broad range of benefits accruing to both trained and untrained tasks, suggests that the investigators approach has great potential to improve the core deficits of the neglect syndrome. Thus, WM training represents a promising avenue for rehabilitating neglect patients who demonstrate core deficits in both spatial attention and VWM to be highly interrelated functions.
Read the detailed description
To examine the relationship between activities of daily living, attention and spatial working memory the investigators will have participants perform a range of clinical and experimental tasks over several sessions of testing. Below is an outline of the tasks to be used (attached are example of all tasks).
- Clinical Tests: Neglect screenings: (a) The Behavioural Inattention Test (BIT) which includes pencil-and-paper or computer tablet tests of line bisection, figure copying and cancellation to assess for neglect. (b) The VRLAT as a more sensitive means to detect Neglect. Participants are asked to navigate through a virtual reality with a joystick. They are instructed to name objects presented on both sides of the virtual path while avoiding colliding with the objects along the way. The task takes approximately 5 minutes to complete. The Montreal Cognitive Assessment (MoCA): a brief screening tool for mild cognitive impairment
- Spatial Attention Tasks: the covert orienting of visual attention task (COVAT), a computer task where participants fixate on a central point and detect targets presented at peripheral locations. Targets are preceded by peripheral cues that attract attention to one side or the other. Targets can appear at the cued location (i.e., a valid trial) or at the uncued location (i.e., an invalid trial). This task takes around 10 minutes to complete.
- Visual Working Memory Task (VWM): One to three coloured squares arranged vertically in right space are presented for 500 ms in a computerized task. Following a delay a probe stimulus (bold rectangle) appears. Participants have to use the mouse to click on a colour bar to match the colour of the target that has previously occupied the highlighted space. This task takes about 30 minutes to complete.
- Activities of daily living: The Frenchay Activities Index (FAI) is a short stroke specific questionnaire to assess functional status.
To assess the effects of working memory training on neglect two groups of neglect participants will be assigned to separate training protocols outlined below. Outcomes measures will include the tests outlined above and the VWM tasks themselves that were used in training.
- Passive SWM training: the first group of participants will perform the VWM task described above, but do not actively engage in any specific component of the task (i.e., they passively respond to the stimuli appearing on the screen).
- Active SWM training: the second training group will perform a task similar to the popular video game Guitar Hero. A sequence of virtual piano keys will be used on a tablet computer to simplify the game. Just as in Guitar Hero, a sequence of coloured targets, each corresponding to a specific piano key will gradually approach a target line at which point participants should hit the corresponding key of the virtual piano. A VWM component will be introduced to the task by presenting participants with a sequence of keys to touch followed by a brief delay. The investigators will manipulate load by changing the number of items in a given sequence (e.g., 1, 2, 3 and 5). After the delay participants will be required to repeat the sequence just presented by tapping the same keys on the tablet.
- Training regimes and outcome measures: Two different lengths of training will be employed for both groups; 2 and 4 weeks, implemented as a between subjects factor. Participants will complete the training protocol for half an hour once per day using the tablet computer.
Outcome measures taken at 2 weeks, 4 weeks, 12 weeks include BIT, VRLAT COVAT, VWM, FAI.
Neglect participants will be contrasted to two control groups: healthy age-matched controls (recruited through WRAP) and a group of right brain damaged (RBD) participants without neglect.
- Conditions
- Hemispatial Neglect
- Being tested
- Working memory training
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
See protocol
| Study group | Role | What they receive |
|---|---|---|
| Active training | Experimental | Patients will undergo active working memory training (see description of protocol). Receives: Behavioral: Working memory training |
| Passive training | Active comparator | Patients will undergo passive working memory training (see description of protocol). Receives: Behavioral: Working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on behavioural tests
Performance on behavioural tests
Measured: Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.
Improvement on self-report measures
Changes to self-reported function in activities of daily living
Measured: Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Danckert, University of Waterloo
- Investigators
- James Danckert, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608190
- Sponsor's protocol ID
- Danckert
- Status last verified
- Jul 2019
- First submitted
- 11 Nov 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Working Memory Training to Rehabilitate Unilateral Visual Neglect
- ClinicalTrials.gov ID
- NCT02608190
- Acronym / sponsor ID
- Danckert
- Conditions
- Hemispatial Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 18 Nov 2015 (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.
Purpose: Stroke is a common cause of death and disability in Canada. Injury to the right hemisphere of the brain and the parietal cortex in particular, is common and results in a disorder known as 'neglect' in 40% to 95% of patients. These patients fail to attend to or respond to events occurring in left space; the disorder is devastating for the patient and their caregivers with the patient becoming dependent on assistance for most activities of daily life (ADLs).
The project will implement two visual working memory (VWM) training programs to explore the influence of VWM training on neglect symptoms as well as activities of daily life.
Hypothesis: It is hypothesised that SWM training protocols will lead to improvements of neglect symptoms as well as improvement in ADLs.
The project will develop a novel rehabilitation strategy for treating the neglect syndrome.
Evidence from research in healthy participants employing video games to improve cognition along with research using working memory training protocols showing a broad range of benefits accruing to both trained and untrained tasks, suggests that the investigators approach has great potential to improve the core deficits of the neglect syndrome. Thus, WM training represents a promising avenue for rehabilitating neglect patients who demonstrate core deficits in both spatial attention and VWM to be highly interrelated functions.
Detailed description
To examine the relationship between activities of daily living, attention and spatial working memory the investigators will have participants perform a range of clinical and experimental tasks over several sessions of testing. Below is an outline of the tasks to be used (attached are example of all tasks).
- Clinical Tests: Neglect screenings: (a) The Behavioural Inattention Test (BIT) which includes pencil-and-paper or computer tablet tests of line bisection, figure copying and cancellation to assess for neglect. (b) The VRLAT as a more sensitive means to detect Neglect. Participants are asked to navigate through a virtual reality with a joystick. They are instructed to name objects presented on both sides of the virtual path while avoiding colliding with the objects along the way. The task takes approximately 5 minutes to complete. The Montreal Cognitive Assessment (MoCA): a brief screening tool for mild cognitive impairment
- Spatial Attention Tasks: the covert orienting of visual attention task (COVAT), a computer task where participants fixate on a central point and detect targets presented at peripheral locations. Targets are preceded by peripheral cues that attract attention to one side or the other. Targets can appear at the cued location (i.e., a valid trial) or at the uncued location (i.e., an invalid trial). This task takes around 10 minutes to complete.
- Visual Working Memory Task (VWM): One to three coloured squares arranged vertically in right space are presented for 500 ms in a computerized task. Following a delay a probe stimulus (bold rectangle) appears. Participants have to use the mouse to click on a colour bar to match the colour of the target that has previously occupied the highlighted space. This task takes about 30 minutes to complete.
- Activities of daily living: The Frenchay Activities Index (FAI) is a short stroke specific questionnaire to assess functional status.
To assess the effects of working memory training on neglect two groups of neglect participants will be assigned to separate training protocols outlined below. Outcomes measures will include the tests outlined above and the VWM tasks themselves that were used in training.
- Passive SWM training: the first group of participants will perform the VWM task described above, but do not actively engage in any specific component of the task (i.e., they passively respond to the stimuli appearing on the screen).
- Active SWM training: the second training group will perform a task similar to the popular video game Guitar Hero. A sequence of virtual piano keys will be used on a tablet computer to simplify the game. Just as in Guitar Hero, a sequence of coloured targets, each corresponding to a specific piano key will gradually approach a target line at which point participants should hit the corresponding key of the virtual piano. A VWM component will be introduced to the task by presenting participants with a sequence of keys to touch followed by a brief delay. The investigators will manipulate load by changing the number of items in a given sequence (e.g., 1, 2, 3 and 5). After the delay participants will be required to repeat the sequence just presented by tapping the same keys on the tablet.
- Training regimes and outcome measures: Two different lengths of training will be employed for both groups; 2 and 4 weeks, implemented as a between subjects factor. Participants will complete the training protocol for half an hour once per day using the tablet computer.
Outcome measures taken at 2 weeks, 4 weeks, 12 weeks include BIT, VRLAT COVAT, VWM, FAI.
Neglect participants will be contrasted to two control groups: healthy age-matched controls (recruited through WRAP) and a group of right brain damaged (RBD) participants without neglect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active training | Experimental | Behavioral: Working memory trainingPatients will undergo active working memory training (see description of protocol). |
| Passive training | Active comparator | Behavioral: Working memory trainingPatients will undergo passive working memory training (see description of protocol). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stroke presence of neglect symptoms
Key exclusion criteria (2 listed)
- any other neurological or psychiatric syndrome
- any incapacity to perform the tasks
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 |
|---|---|---|
| Working memory trainingSee protocol | Behavioural | Active training, Passive training |
Primary outcome
Improvement on behavioural tests
Time frame: Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.
Performance on behavioural tests
Improvement on self-report measures
Time frame: Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.
Changes to self-reported function in activities of daily living
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 29 Jul 2019.
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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. This study is not recruiting at the moment.
James Danckert, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory training in people with Hemispatial Neglect, run by University of Waterloo 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 1 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 29 Jul 2019. 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. 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?
Improvement on behavioural tests (time frame: Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.