Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment. (MCI)
Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
Background:
Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.
Objectives:
The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.
Patients and Methods:
The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.
Relevance:
Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Aust-Agder
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Arendal、Aust-Agder、ノルウェー、4838
- 募集
- Sorlandet Hospital HF
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コンタクト：
- Susanne S Hernes, MD
- 電話番号：0047-48136020
- メール：susanne.sorensen.hernes@sshf.no
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Patients who meet the Peterson diagnostic criteria of MCI:
- memory complaints (preferably confirmed by an informant).
- memory impairment according to age and education.
- preserved general cognitive function.
- intact activities of daily living, absence of dementia.
Exclusion Criteria:
- head trauma with post-traumatic loss of conscience for 30 minutes during lifespan.
- loss of senses (blindness, deafness).
- photo-sensitive epilepsy.
- unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia.
- drug and/or alcohol abuse.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：Computerized Working Memory Training.
The Working Memory Training, includes both auditive and visual tasks, administrated on a computer, under guidance.
5 x 45 minutes per week, for 5 weeks.
The placebo group will train at an fixed level (non-adaptive), but with otherwise identical computer programs.
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Auditive and visual Working Memory tasks, administrated on a computer under guidance.
5 x 45 minutes per week, for 5 weeks.
The intervention group will train at an "adaptive" level that is not to difficult nor to easy, which is hypothesized as optimal for learning and training effect.
The placebo group will train with a "sham" program that is fixed ("non-adaptive" in difficulty level), but otherwise identical.
他の名前：
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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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Working Memory function.
時間枠：Changes from baseline (3, 6 and 12 months after intervention).
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The study seeks to assess changes in the patients working memory function after an intervention of working memory training.The construct of "Working Memory" is measured on several levels: by neuropsychological tests (cognitive level), assessment of daily living skills (ADL-level), and measures of changes in the brains white and gray matter in areas that are correlated with working memory function (brain level).
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Changes from baseline (3, 6 and 12 months after intervention).
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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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Episodic memory function.
時間枠：Changes from baseline (3, 6 and 12 months after intervention).
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We will measure the patients results on a word list task, both immediate and delayed recall, as well as recognition.
Low scores on word list learning is associated with progression to dementia.
It is anticipated that patients with MCI are at risk for developing dementia.
The study seeks to investigate if there is a correlation between the results on memory tests and progression to dementia in this patient group.
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Changes from baseline (3, 6 and 12 months after intervention).
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Svein Gunnar Gundersen, PhD、Head of research department
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MCI Working Memory Training.
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