search
Back to results

Rehabilitating Unilateral Neglect Using Spatial Working Memory Training

Primary Purpose

Hemispatial Neglect

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Working memory training
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemispatial Neglect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • stroke presence of neglect symptoms

Exclusion Criteria:

  • any other neurological or psychiatric syndrome
  • any incapacity to perform the tasks

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active training

Passive training

Arm Description

Patients will undergo active working memory training (see description of protocol).

Patients will undergo passive working memory training (see description of protocol).

Outcomes

Primary Outcome Measures

Improvement on behavioural tests
Performance on behavioural tests
Improvement on self-report measures
Changes to self-reported function in activities of daily living

Secondary Outcome Measures

Full Information

First Posted
November 11, 2015
Last Updated
July 26, 2019
Sponsor
University of Waterloo
search

1. Study Identification

Unique Protocol Identification Number
NCT02608190
Brief Title
Rehabilitating Unilateral Neglect Using Spatial Working Memory Training
Official Title
Using Working Memory Training to Rehabilitate Unilateral Visual Neglect
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active training
Arm Type
Experimental
Arm Description
Patients will undergo active working memory training (see description of protocol).
Arm Title
Passive training
Arm Type
Active Comparator
Arm Description
Patients will undergo passive working memory training (see description of protocol).
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Description
See protocol
Primary Outcome Measure Information:
Title
Improvement on behavioural tests
Description
Performance on behavioural tests
Time Frame
Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.
Title
Improvement on self-report measures
Description
Changes to self-reported function in activities of daily living
Time Frame
Measured at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: stroke presence of neglect symptoms Exclusion Criteria: any other neurological or psychiatric syndrome any incapacity to perform the tasks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Danckert, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Rehabilitating Unilateral Neglect Using Spatial Working Memory Training

We'll reach out to this number within 24 hrs