Exploring the Long-term Effects of Cognitive Exercise on Cognition After Stroke
2015年9月17日 更新者：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.
調査の概要
状態
終了しました
詳細な説明
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.
研究の種類
介入
入学 (実際)
2
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 4R2
- Dalhousie University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline Flanker Effects at 10 weeks
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline Raven's Matrices Scores at 10 weeks
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The Fatigue Severity Scale
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Graham C Wilson, BSc、Dalhousie University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年9月1日
一次修了 (実際)
2014年11月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2013年9月3日
QC基準を満たした最初の提出物
2013年9月20日
最初の投稿 (見積もり)
2013年9月23日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年9月18日
QC基準を満たした最後の更新が送信されました
2015年9月17日
最終確認日
2013年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。