Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke
17 de setembro de 2015 atualizado por: Nova Scotia Health Authority
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.
Visão geral do estudo
Status
Rescindido
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
2
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 4R2
- Dalhousie University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
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Experimental: 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.
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Flanker Effects at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Raven's Matrices Scores at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Change from Baseline Montreal Cognitive Assessment Scores at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Montreal Cognitive Assessment is a well-known screening tool for mild cognitive impairment.
This test is a measure of overall cognitive abilities.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Change from Baseline Networks of Attention Battery scores at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Change from Baseline Sternberg Digit Memory scores at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Change from Baseline Cognitive Failures Questionnaire Scores at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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).
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Change from Baseline Hospital Anxiety and Depression Scale (HADS) at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Cognitive Activities Questionnaire and the Physical Activity Scale for the Elderly (PASE)
Prazo: Participants will be assessed during the duration of the study, an expected average of 10 weeks
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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.
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Participants will be assessed during the duration of the study, an expected average of 10 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Fatigue Severity Scale
Prazo: Participants will be assessed during the duration of the study, an expected average of 10 weeks
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The Fatigue Severity Scale is a brief 9-item questionnaire designed to assess patient fatigue.
This scale is commonly used for the stroke population.
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Participants will be assessed during the duration of the study, an expected average of 10 weeks
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Participant Satisfaction
Prazo: Participants will be assessed during the duration of the study, an expected average of 10 weeks
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Participants will be asked a set of structured questions about their response to the training itself - difficulty, enjoyability, response to using a computer, etc.
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Participants will be assessed during the duration of the study, an expected average of 10 weeks
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Change from Baseline Event Related Potentials using Cortical Activity Electroencephalography at 10 weeks
Prazo: The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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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.
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The participants will be assessed on session 1 of week 1 and on session 31 of week 10
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Graham C Wilson, BSc, Dalhousie University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2013
Conclusão Primária (Real)
1 de novembro de 2014
Conclusão do estudo (Real)
1 de novembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
3 de setembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de setembro de 2013
Primeira postagem (Estimativa)
23 de setembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de setembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de setembro de 2015
Última verificação
1 de agosto de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Ext-Prim-12
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