Clinical trial NCT01948089: Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Phase Stroke Patients
Keywords: Chronic Stroke
near transfer
far transfer
working memory
fluid intelligence
cognitive training
dual n-back
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will investigate the effectiveness of an intensive and focused working memory training program for chronic stroke patients. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in this population.

Detailed description: Vascular cognitive impairment due to vascular disease and stroke frequently includes problems with attention, working memory and executive functions (e.g., monitoring, planning, and organization).

These deficits are common - 32-73%, and chronic, and interfere with a patients response to rehabilitation, independence in activities of daily living, community re-integration, and overall quality of life after stroke. Attention, memory and executive function impairments can adversely affect the ability to relearn various skills.

Cognitive impairments and their impacts on other components of functioning not only impact on the individual, but can also adversely affect the family via increases in caregiver distress and burden. Thus, the presence of cognitive impairment has wide-reaching impact and deserves effective and consistent intervention similar to the attention devoted to improving function in physical domains.

Cognitive training can improve cognitive function, particularly in those areas known to involved in vascular cognitive impairment, i.e., attentional and executive function. Accumulating evidence indicates that computer-based training can improve cognitive skills in healthy older adults as well as in clinical populations. Attention and working memory training has also been shown to be effective in patients in the chronic phase post stroke.

The investigators propose that specific cognitive training to improve working memory could provide direct benefit to chronic stroke patients. Promising interventions focused on intensive and direct working memory training are emerging and have been shown to generalize to other cognitive domains, such as fluid intelligence.

Eligibility criteria: Inclusion Criteria:

* Subjects must: (i) be ≥18 years of age, (ii) have been received the diagnosis of ischemic or hemorrhagic stroke \>6 months ago, (iii) be experiencing stroke-related cognitive problems that interfere with daily functioning, (iv) be able to perform a two-step command, (v) live within a 75 km radius of the Queen Elizabeth II

Exclusion Criteria:

* Subjects must not: (i) have moderate or severe receptive aphasia, (ii) have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness.

Primary outcomes:
measure: Change from Baseline Flanker Effects at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Secondary outcomes:
measure: Change from Baseline Raven's Matrices Scores at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Change from Baseline Montreal Cognitive Assessment Scores at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Change from Baseline Networks of Attention Battery scores at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Change from Baseline Sternberg Digit Memory scores at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Change from Baseline Cognitive Failures Questionnaire Scores at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Change from Baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
measure: Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE)
timeFrame: Participants will be assessed during the duration of the study, an expected average of 10 weeks
Other outcomes:
measure: The Fatigue Severity Scale
timeFrame: Participants will be assessed during the duration of the study, an expected average of 10 weeks
measure: Participant Satisfaction
timeFrame: Participants will be assessed during the duration of the study, an expected average of 10 weeks
measure: Change from Baseline Event Related Potentials using Cortical Activity Electroencephalography at 10 weeks
timeFrame: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Graham C Wilson, BSc
role: PRINCIPAL_INVESTIGATOR
References: