NCT02608190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

November 11, 2015

Last Update Submit

July 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Improvement on behavioural tests

    Performance on behavioural tests

    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 at time zero (after intervention), 2 and 4 weeks post and 3 months post intervention.

Study Arms (2)

Active training

EXPERIMENTAL

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

Behavioral: Working memory training

Passive training

ACTIVE COMPARATOR

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

Behavioral: Working memory training

Interventions

See protocol

Active trainingPassive training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke presence of neglect symptoms

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James Danckert, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 18, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations