Brain Fitness APP for Aging With a Healthy Brain
Brain Fitness APP for Aging With a Healthy Brain and Detecting Cognitive Declines
Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. While currently there is no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy life style. The proposed research offers a novel approach to prevent dementia and age-related cognitive disorders.
It is proposed to create a brain fitness APP for the aging population. The proposed APP is based on the premise of brain plasticity, and targets the brain functions that are declining with normal aging and dementia.
The proposed APP will be tested on a large population with statistical rigor (60 healthy individuals of age 65+ years and up to 30 individuals with cognitive impairment); the participants will be divided into an intervention group and a control group. We will analyze the logged performance of the participants, and assess their cognitive state with an independent test compared to a matched control group before and after the trial.
It is anticipated that the frequent use of the proposed APP will help to maintain a healthy brain as well as detecting the onset of a cognitive decline in aging population. In addition, its frequent use will slow and even reverse the progression of the cognition decline in individuals with mild cognitive impairment or dementia. The APP will have many different levels of difficulty so that it can be applied to a wide age range and conditions.
調査の概要
詳細な説明
The research is on the frequent use of our designed APP (for iPADs) that contains a series of our recently developed brain exercises that contains a series of our recently developed brain exercises, including orientation, associative memory, word-image association, recall memory, etc.
Participants will be randomly assigned to either Intervention or Control Arm. Participants of Intervention Arm must have access to an iPAD at least for the duration of the study.
Procedure for Intervention Arm The participants in Intervention Arm will have a training session (after obtaining their consent form) for the Brain Exercises. The Brain Fitness App will be downloaded into their iPAD and they will be instructed on how to use it. As mentioned in their consent form, they will commit themselves to play the games on a daily basis for (at least 5 days/week), twice/day, each session of minimum 15 minutes for a period of 4 consecutive weeks.
Procedure for Control Arm Participants of this arm will do nothing but will be assessed at baseline, 4 week and 8 weeks later. Their data will be used as the control data for comparison with the Intervention Arm data. All participants of this group, if interested, will be offered to practice the Brain Fitness App if they wish after their completion of this study (2 months period).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3L 2P4
- Riverview Health Center
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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:
- MoCA ≥ 25
- Have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, dementia of any type, or any other neurological degenerative disease.
- Capable of using an iPAD and access to Internet at home.
- Reading/writing fluency in English
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：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Active
4 weeks daily practice of the brain exercises
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Brain exercises using an iPAD
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介入なし：control
no brain exercises
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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 |
|---|---|---|
|
The change in Wechsler Memory Scale (WMS IV) from baseline
時間枠：baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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This assessment has a total of 11 tests, out of which we will use its six primary tests that assess our target brain functions, comprised of 12 subtests (subsections): Logical Memory 1, Verbal Paired Associates 1, Faces 1, Family Pictures 1, Logical Memory 2, Verbal Paired Associates 2, Faces 2, Family Pictures 2, Verbal Paired Associates 2 Recognition, Logical Memory 2 Recognition, Letter-Number Sequencing and Spatial Span.
They are classified into 3 major memory indexes: Immediate Memory, General Memory and Working Memory.
The WMS test is being purchased online from the following link; they do not provide a softcopy.
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baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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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 |
|---|---|---|
|
Change in Egocentric Spatial Orientation
時間枠：baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
|
This test is one of the PI's designs that has been in use since a few years ago.
It is used for detecting the onset of Alzheimer's.
In this test participants sit in a customized wheelchair and by waking the wheelchair they move within a virtual cubic building to reach a particular target room.
They can do this test either using the laptop screen or in its immersive version wearing a goggle (Oculus Rift 2).
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baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
時間枠：baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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The MADRS is a ten item rating scale for rating levels of depression.
Each item is rated on a 7-point scale from 0 to 6, where 0 indicates absence of the symptom and 6 indicates extreme presence of the symptom.
The time frame for the scale is the previous four weeks.
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baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- B2018:029
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Brain Fitness Appの臨床試験
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Rousselot BVBAKGK Science Inc.まだ募集していません
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Guillermo Ceballos ReyesInstituto de Seguridad y Servicios Sociales de los Trabajadores del Estado完了
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University of Valencia完了
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Beijing Pins Medical Co., LtdBeijing Tiantan Hospitalわからない
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Centre Hospitalier Universitaire de Saint Etienne完了
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University of Electronic Science and Technology...募集