White Matter Connections and Memory: the STRATEGIC Study (STRATEGIC)
2019年6月7日 更新者：Dr Mike O'Sullivan、King's College London
In patients who have had a stroke, memory problems are common.
Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable.
The STRATEGIC study assesses patients with recent stroke and follows them up after one year.
The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.
調査の概要
詳細な説明
Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.
Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.
The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.
研究の種類
観察的
入学 (実際)
193
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
50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
サンプリング方法
非確率サンプル
調査対象母集団
Patients with recent ischaemic stroke.
説明
Inclusion Criteria:
- Aged over 50 years
- Recent ischaemic stroke
- English is first language
Exclusion Criteria:
- Previous large artery infarct
- Major neurological or psychiatric condition
- Moderate to severe head injury (Mayo classification)
- Dementia
- Severe cardiac failure
- Active malignancy
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
コホートと介入
グループ/コホート |
|---|
|
Stroke patients
Patients with recent ischaemic stroke
|
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 |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) score at 30-90 days
時間枠：30-90 days after stroke
|
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org |
30-90 days after stroke
|
|
Montreal Cognitive Assessment (MoCA) score at one year
時間枠：One year after stroke
|
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org |
One year after stroke
|
|
Montreal Cognitive Assessment (MoCA), change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The MoCA is a widely used test measuring across several cognitive domains. It gives a score out of 30. https://www.mocatest.org |
From 30-90 days after stroke to one year after stroke
|
|
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at 30-90 days
時間枠：30-90 days after stroke
|
The FCSRT tests how well participants can remember 16 words.
Participants make three attempts, giving a total score out of 48.
The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987).
Genuine memory deficits in dementia.
Developmental Neuropsychology, 3, 13-36.
|
30-90 days after stroke
|
|
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT) at one year
時間枠：One year after stroke
|
The FCSRT tests how well participants can remember 16 words.
Participants make three attempts, giving a total score out of 48.
The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987).
Genuine memory deficits in dementia.
Developmental Neuropsychology, 3, 13-36.
|
One year after stroke
|
|
Verbal free recall score on the Free and Cued Selective Reminding Task (FSCRT), change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The FCSRT tests how well participants can remember 16 words.
Participants make three attempts, giving a total score out of 48.
The test has been widely used in studies of memory and is described in Grober, E., & Buschke, H. (1987).
Genuine memory deficits in dementia.
Developmental Neuropsychology, 3, 13-36.
|
From 30-90 days after stroke to one year after stroke
|
|
Backward digit span score at 30-90 days
時間枠：30-90 days after stroke.
|
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV.
In the test participants must repeat a sequence of digits.
Sequences are repeated at increasing length until the participant makes two errors at the same length.
The test comprises two parts.
In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order.
This outcome measure takes the total correct responses in reverse order.
Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
|
30-90 days after stroke.
|
|
Backward digit span score at one year
時間枠：One year after stroke
|
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV.
In the test participants must repeat a sequence of digits.
Sequences are repeated at increasing length until the participant makes two errors at the same length.
The test comprises two parts.
In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order.
This outcome measure takes the total correct responses in reverse order.
Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
|
One year after stroke
|
|
Backward digit span score, change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The digit span test measures working memory and is taken from the Wechsler Adult Intelligence Scale IV.
In the test participants must repeat a sequence of digits.
Sequences are repeated at increasing length until the participant makes two errors at the same length.
The test comprises two parts.
In the first, participants repeat sequences is the order given; in the second they repeat sequences in reverse order.
This outcome measure takes the total correct responses in reverse order.
Sequence lengths are between two and seven digits, with to sequences of each length, giving a maximum score of 12.
|
From 30-90 days after stroke to one year after stroke
|
|
Paired Associate Learning (PAL) recognition score at 30-90 days
時間枠：30-90 days after stroke.
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recognition score is the number of correct choices when given two possible locations for a given object.
Each object is tested three times, giving a maximum score of 30.
|
30-90 days after stroke.
|
|
Paired Associate Learning (PAL) recognition score at one year
時間枠：One year after stroke.
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recognition score is the number of correct choices when given two possible locations for a given object.
Each object is tested three times, giving a maximum score of 30.
|
One year after stroke.
|
|
Paired Associate Learning (PAL) recognition score, change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recognition score is the number of correct choices when given two possible locations for a given object.
Each object is tested three times, giving a maximum score of 30.
|
From 30-90 days after stroke to one year after stroke
|
|
Paired Associate Learning (PAL) recall score at 30-90 days
時間枠：30-90 days after stroke
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
|
30-90 days after stroke
|
|
Paired Associate Learning (PAL) recall score at one year
時間枠：One year after stroke
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
|
One year after stroke
|
|
Paired Associate Learning (PAL) recall score, change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The PAL task measures participants' ability to associate two items of information in memory.
In this study, participants must learn a set of ten objects and their associated locations.
The recall score measures participants ability to recall which object was present at each location (a maximum of 10).
|
From 30-90 days after stroke to one year after stroke
|
|
Process Dissociation Procedure (PDP) familiarity score at 30-90 days
時間枠：30-90 days after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
30-90 days after stroke
|
|
Process Dissociation Procedure (PDP) familiarity score at one year
時間枠：One year after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
One year after stroke
|
|
Process Dissociation Procedure (PDP) familiarity score, change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
From 30-90 days after stroke to one year after stroke
|
|
Process Dissociation Procedure (PDP) recollection score at 30-90 days
時間枠：30-90 days after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
30-90 days after stroke
|
|
Process Dissociation Procedure (PDP) recollection score at one year
時間枠：One year after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
One year after stroke
|
|
Process Dissociation Procedure (PDP) recollection score, change in score over one year
時間枠：From 30-90 days after stroke to one year after stroke
|
The PDP is a word memory test.
Participants first read out loud a set of words.
They are then presented with incomplete words and must fill in the missing letters.
In one part of the test, participants must use one of the remembered words whenever possible.
In the other part of the test, they must avoid the remembered words.
The two parts are designed to dissociate two types of memory: familiarity and recollection.
Familiarity is the unconscious remembering of a word because it was previously seen, which is an advantage when including the words, but a disadvantage when avoiding them.
Recollection is the conscious remembering of a word and the context where it was encountered.
This is an advantage in both parts of the test.
The scores in each part of the test are combined to compute scores for familiarity and recollection, each in percent.
|
From 30-90 days after stroke to one year after stroke
|
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。
スポンサー
捜査官
- 主任研究者：Michael J O'Sullivan, MBBS,PhD、King's College London and University of Queensland
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 (実際)
2014年4月11日
一次修了 (実際)
2017年6月7日
研究の完了 (予想される)
2022年4月30日
試験登録日
最初に提出
2018年11月23日
QC基準を満たした最初の提出物
2019年6月7日
最初の投稿 (実際)
2019年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月11日
QC基準を満たした最後の更新が送信されました
2019年6月7日
最終確認日
2019年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- KCH14-072
- 13/LO/1745 (その他の識別子：London Bromley Research Ethics Committee)
- K022113 (その他の助成金/資金番号：Medical Research Council, UK)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
If possible, we hope to share anonymised test scores and derived MRI measures, along with demographic and other background data.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。