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

NCT ID: NCT01948089

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-11-30

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.

Conditions

Chronic Phase Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Variable Structured Cognitive Exercise

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.

Group Type: EXPERIMENTAL

Variable Structured Cognitive Exercise

Intervention Type: BEHAVIORAL

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.

Constant Structured Cognitive Exercise

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.

Group Type: EXPERIMENTAL

Constant Structured Cognitive Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Variable Structured Cognitive Exercise

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

Constant Structured Cognitive Exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graham C Wilson, BSc

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

Ext-Prim-12

Identifier Type: -

Identifier Source: org_study_id