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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • University of Waterloo

    Waterloo, Ontario, N2L 3G1

Other trials in Canada

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).

  1. 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
  2. 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.
  3. 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.
  4. 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.

  1. 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).
  2. 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.
  3. 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.

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 groups in NCT02608190
Study groupRoleWhat they receive
Active trainingExperimentalPatients will undergo active working memory training (see description of protocol).
Receives: Behavioral: Working memory training
Passive trainingActive comparatorPatients 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.

  1. 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.

  2. 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.

  1. First posted18 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJul 2019
  4. Study completionJul 2019

Resources

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)
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

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.

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