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Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke

Primary Purpose

Chronic Phase Stroke Patients

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Variable Structured Cognitive Exercise
Constant Structured Cognitive Exercise
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Phase Stroke Patients focused on measuring Chronic Stroke, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Variable Structured Cognitive Exercise

Constant Structured Cognitive Exercise

Arm Description

This training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. Each participant will receive 30 minutes of cognitive exercise per day, 3 days a week for 10 weeks.

This training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. Each participant will receive 30 minutes of cognitive exercise per day, 3 days a week for 10 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline Flanker Effects at 10 weeks
Flanker test [primary study outcome] is a computerized test of selective attention and reaction time that involves a motor response. The participant needs to focus and identify an item presented on a screen while ignoring task-irrelevant distracters. Performance on this test has been shown to improve with exercise

Secondary Outcome Measures

Change from Baseline Raven's Matrices Scores at 10 weeks
Raven's Matrices Test is a measure of non-verbal reasoning ability and fluid intelligence (i.e., ability to solve new problems independently of previously acquired knowledge, which is critical to learning). This test will examine the far transfer of training to a problem-solving task. Dual n-back training has shown to improve performance on this test.
Change from Baseline Montreal Cognitive Assessment Scores at 10 weeks
Montreal Cognitive Assessment is a well-known screening tool for mild cognitive impairment. This test is a measure of overall cognitive abilities.
Change from Baseline Networks of Attention Battery scores at 10 weeks
Networks of Attention battery is a computerized battery that provides performance data on tests of vigilance (simple and choice reaction time), orienting and selection (visual search) and executive control (dual tasking, working memory, inhibition). This battery will allow the attention and working memory deficits to be characterized for each patient and serve as near and far transfer measures of training effects.
Change from Baseline Sternberg Digit Memory scores at 10 weeks
Sternberg digit memory task is a measure of visual working memory wherein the subject is shown a set of n digits for study. After a short delay, a digit is shown and the subject is asked to recall whether that item was in the previously viewed set. This test will examine the near transfer of training to another working memory test.
Change from Baseline Cognitive Failures Questionnaire Scores at 10 weeks
Cognitive Failures Questionnaire is a measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function, for example, "Do you find you forget why you went from one part of the house to the other?" It has high internal validity (alpha=0.91) and good test-retest reliability (r= 0.82).
Change from Baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
Hospital Anxiety and Depression Scale (HADS) consists of 14 items, divided into two 7-item subscales (Anxiety and Depression). HADS has been reported to be an 'acceptable' screening tool for anxiety and depression after stroke.
Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE)
Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE) will be conducted to determine the extent of cognitive and physical activities, respectively, during the 10-week interval.

Full Information

First Posted
September 3, 2013
Last Updated
September 17, 2015
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01948089
Brief Title
Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Phase Stroke Patients
Keywords
Chronic Stroke, near transfer, far transfer, working memory, fluid intelligence, cognitive training, dual n-back

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Variable Structured Cognitive Exercise
Arm Type
Experimental
Arm Description
This training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. Each participant will receive 30 minutes of cognitive exercise per day, 3 days a week for 10 weeks.
Arm Title
Constant Structured Cognitive Exercise
Arm Type
Experimental
Arm Description
This training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. Each participant will receive 30 minutes of cognitive exercise per day, 3 days a week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Variable Structured Cognitive Exercise
Intervention Description
This exercise uses the n-back paradigm in which participants are asked to keep track of one or two series of sequentially presented auditory and/or visual stimuli in order to detect targets that match those presented n-items ago in the sequence. The task begins at 1-back (i.e., watch for targets that match those just presented) and gets harder (e.g., watch for matches with items presented 2 or 3 items ago in the sequence) as performance improves. The stimuli will vary weekly, and include varying auditory letters or words, or varying visual patterns or faces.
Intervention Type
Behavioral
Intervention Name(s)
Constant Structured Cognitive Exercise
Intervention Description
This exercise uses the n-back paradigm in which participants are asked to keep track of one or two series of sequentially presented auditory and/or visual stimuli in order to detect targets that match those presented n-items ago in the sequence. The task begins at 1-back (i.e., watch for targets that match those just presented) and gets harder (e.g., watch for matches with items presented 2 or 3 items ago in the sequence) as performance improves. The stimuli will remain constant throughout the 10 week intervention
Primary Outcome Measure Information:
Title
Change from Baseline Flanker Effects at 10 weeks
Description
Flanker test [primary study outcome] is a computerized test of selective attention and reaction time that involves a motor response. The participant needs to focus and identify an item presented on a screen while ignoring task-irrelevant distracters. Performance on this test has been shown to improve with exercise
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Secondary Outcome Measure Information:
Title
Change from Baseline Raven's Matrices Scores at 10 weeks
Description
Raven's Matrices Test is a measure of non-verbal reasoning ability and fluid intelligence (i.e., ability to solve new problems independently of previously acquired knowledge, which is critical to learning). This test will examine the far transfer of training to a problem-solving task. Dual n-back training has shown to improve performance on this test.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Change from Baseline Montreal Cognitive Assessment Scores at 10 weeks
Description
Montreal Cognitive Assessment is a well-known screening tool for mild cognitive impairment. This test is a measure of overall cognitive abilities.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Change from Baseline Networks of Attention Battery scores at 10 weeks
Description
Networks of Attention battery is a computerized battery that provides performance data on tests of vigilance (simple and choice reaction time), orienting and selection (visual search) and executive control (dual tasking, working memory, inhibition). This battery will allow the attention and working memory deficits to be characterized for each patient and serve as near and far transfer measures of training effects.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Change from Baseline Sternberg Digit Memory scores at 10 weeks
Description
Sternberg digit memory task is a measure of visual working memory wherein the subject is shown a set of n digits for study. After a short delay, a digit is shown and the subject is asked to recall whether that item was in the previously viewed set. This test will examine the near transfer of training to another working memory test.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Change from Baseline Cognitive Failures Questionnaire Scores at 10 weeks
Description
Cognitive Failures Questionnaire is a measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function, for example, "Do you find you forget why you went from one part of the house to the other?" It has high internal validity (alpha=0.91) and good test-retest reliability (r= 0.82).
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Change from Baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
Description
Hospital Anxiety and Depression Scale (HADS) consists of 14 items, divided into two 7-item subscales (Anxiety and Depression). HADS has been reported to be an 'acceptable' screening tool for anxiety and depression after stroke.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10
Title
Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE)
Description
Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE) will be conducted to determine the extent of cognitive and physical activities, respectively, during the 10-week interval.
Time Frame
Participants will be assessed during the duration of the study, an expected average of 10 weeks
Other Pre-specified Outcome Measures:
Title
The Fatigue Severity Scale
Description
The Fatigue Severity Scale is a brief 9-item questionnaire designed to assess patient fatigue. This scale is commonly used for the stroke population.
Time Frame
Participants will be assessed during the duration of the study, an expected average of 10 weeks
Title
Participant Satisfaction
Description
Participants will be asked a set of structured questions about their response to the training itself - difficulty, enjoyability, response to using a computer, etc.
Time Frame
Participants will be assessed during the duration of the study, an expected average of 10 weeks
Title
Change from Baseline Event Related Potentials using Cortical Activity Electroencephalography at 10 weeks
Description
Cortical activity Electroencephalography technology will be used to measure cortical activity. Stimulus presentation and participant response on the computerized Flanker test will be synchronized with EEG data acquisition. Numeric 'triggers' will be placed on the continuous EEG waveform corresponding to stimulus presentation and participant response. Data synchronization is necessary to perform event related potential (ERP) analysis to obtain the P3 component. 150 trials (~5.5 seconds per trial) will be processed using a "SynAmps" response time 128 channel EEG system from 18 scalp electrodes at a sampling rate of 1000 Hz for a total EEG data collection time of ~20 minutes. Electrodes around the eyes will allow detection and removal of trials with ocular artifacts.
Time Frame
The participants will be assessed on session 1 of week 1 and on session 31 of week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham C Wilson, BSc
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada

12. IPD Sharing Statement

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Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke

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