The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial
Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.
Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.
Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.
Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.
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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Hong Kong、香港、Hung Hom
- 募集
- The Hong Kong Polytechnic University
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コンタクト：
- Pablo Cruz Gonzalez
- 電話番号：+85262382024
- メール：pablo.cruzgonzalez@connect.polyu.hk
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コンタクト：
- Kenneth Fong
- 電話番号：+85227666716
- メール：rsnkfong@polyu.edu.hk
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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:
The inclusion criteria will follow the modified Petersen's criteria:
- Aged between 60 and 85 years old;
- Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
- Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
- Self-reported cognitive decline by the participants themselves and
Being independent in daily living activities.
Additional criteria in this study include:
- Having completed three or more years of primary education;
- Ability to participate in a therapy session lasting at least 30 minutes;
- Community ambulant with or without aids; and
- Ability to perform a proper range of motion with hands in order to use a tablet PC.
Exclusion Criteria:
- 1) Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
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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実験的：tDCS+CT
application of tDCS in combination with CT
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経頭蓋直流刺激
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偽コンパレータ：Sham tDCS
application of sham tDCS in combination with CT
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経頭蓋直流刺激
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アクティブコンパレータ：CT
application of CT
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経頭蓋直流刺激
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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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Montreal Cognitive Assessment (MoCA)
時間枠：10 minutes
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It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
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10 minutes
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Digit Span Test
時間枠：10 minutes
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The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order.
Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.
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10 minutes
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Trial Making Test (TMT)
時間枠：5 minutes
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TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected.
Time performance is measured as the main outcome
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5 minutes
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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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Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
時間枠：40 minutes
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It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory.
Additionally prospective memory skills and the ability to learn new information are measured as well
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40 minutes
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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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Cognitive training activities ( Neuronup cognitive training)
時間枠：30 minutes each session ( 9 sessions in total)
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Performance of the cognitive training activities conducted every session
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30 minutes each session ( 9 sessions in total)
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EEG
時間枠：15 minutes
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time and spatial responses of tDCS on the brain cortex before and after tDCS application
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15 minutes
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協力者と研究者
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 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。
tDCSの臨床試験
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Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de Andalucía, Spain招待による登録
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Hôpital le Vinatier完了統合失調症 | 幻聴フランス, チュニジア
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Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)わからない
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了
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Xuanwu Hospital, BeijingBeijing Tiantan Hospital; Second Affiliated Hospital of Tsinghua Universityまだ募集していません神経因性疼痛