てんかん患者の睡眠と記憶に対する聴覚刺激の影響
海馬電極が埋め込まれたてんかん入院患者における調整された非レム睡眠振動と記憶に対する聴覚刺激の影響
This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.
調査の概要
状態
条件
詳細な説明
The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.
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
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
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:
- Inpatients with epilepsy
- Aged 12-65
- Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes
- Fluent in English
- Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)
Exclusion Criteria:
- Intellectual disability impairing ability to perform task
- Motor problems that preclude finger tapping task
- Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest
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：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Epilepsy inpatients
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring |
Hippocampal and scalp EEG monitoring during overnight sleep Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning |
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 |
|---|---|---|
|
Changes in slow oscillation-spindle-hippocampal ripple coupling
時間枠：Three nights of sleep within three weeks
|
Changes in the coupling of slow oscillations with spindles and hippocampal ripples during non-Rapid Eye Movement (NREM) sleep as measured by scalp and intracranial EEG between baseline, memory, and auditory stimulation nights. |
Three nights of sleep within three weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in sleep-dependent consolidation of motor procedural memory
時間枠：Three nights of sleep within three weeks
|
Changes in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between baseline, memory, and auditory stimulation nights. Different sequences are employed for the memory and auditory stimulation nights in a counter-balanced order. |
Three nights of sleep within three weeks
|
|
Changes in slow oscillations
時間枠：Three nights of sleep within three weeks
|
Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
|
Changes in sleep spindles
時間枠：Three nights of sleep within three weeks
|
Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
|
Changes in hippocampal ripples
時間枠：Three nights of sleep within three weeks
|
Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights |
Three nights of sleep within three weeks
|
協力者と研究者
捜査官
- 主任研究者：Dara Manoach, PhD、Professor
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
- 2020P003959
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?
IPD プランの説明
The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. The institution and the PI will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources. Prevailing standards and guidelines in documenting and depositing data sets will be followed. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, starting one year following the completion of the project. Workflows will be documented and will allow any external groups to reproduce results from the raw data. The PI will be responsible for overseeing the sharing the data. Raw and summary data will be submitted to the appropriate NIMH Data Archive annually, including The National Database for Clinical Trials Related to Mental Illness (NDCT).
IPD 共有時間枠
Data will be available one year following the completion of the project.
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。