- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03130322
SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)
Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Bron, Франция, 69500
- CH Le Vinatier
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Healthy right-handed persons without neurologic disease
- Persons having signed informed consent for a neuroimagery study
Exclusion Criteria:
- Persons under curatorship or any administrative/judicial measure
- Participants refusing to be informed of the results of the experiment
- Pregnant women
- Participants with contraindications to the MEG examination: head size, presence of a neurostimulator, steel pivot for the root canal, metallic fragments, ear implants, metal screws in the body or mouth.
- Persons using a pacemaker, insulin pump, or working regularly with iron filings
- Claustrophobic persons
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Нерандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: NightPP
Participants of the NightPP will be subjected to one MRI session and two MEG recording sessions: the first one before a physical practice session of the two motor tasks investigated in the study, and second MEG session right after practice.
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Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep
Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h). Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible.
Participants of the Day group perform a block of motor imagery practice of the two motor tasks.
Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test)
The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
|
Экспериментальный: NightMI
Participants of the NightMI will be subjected to one MRI session and two MEG recording sessions: the first one before a motor imagery practice session of the two motor tasks investigated in the study, and second MEG session right after practice.
|
Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep
Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h). Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible.
Participants of the Day group perform a block of motor imagery practice of the two motor tasks.
Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test)
The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
|
Экспериментальный: NightCtrl
Participants of the NightCtrl will be subjected to one MRI session and two MEG recording sessions: the first one before a mental rotation practice session, a second MEG session right after practice,and second MEG session right after practice.
|
Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep
Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h). Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible.
Participants of the Day group perform a block of motor imagery practice of the two motor tasks.
Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test)
The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
|
Экспериментальный: Day
Participants of the NightMI will be subjected to one MRI session and two MEG recording sessions: the first one before a motor imagery practice session of the two motor tasks investigated in the study, and second MEG session right after practice.
|
Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep
Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h). Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible.
Participants of the Day group perform a block of motor imagery practice of the two motor tasks.
Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test)
The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Evidence of MEG correlates of sleep motor consolidation (day 1)
Временное ограничение: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
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The investigator will use Single Aperture Magnetometry, i.e. a minimum variance beamformer mapping the spatial distribution of event-related desynchronizations and synchronizations within a predetermined frequency domain (Beta oscillations 15-35 Hz).
The time course of MEG Beta power will be considered, and Granger causal connectivity analyses will be performed to investigate relationships between cortical motor regions.
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Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
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Evidence of MEG correlates of sleep motor consolidation (day 2)
Временное ограничение: Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
The investigator will use Single Aperture Magnetometry, i.e. a minimum variance beamformer mapping the spatial distribution of event-related desynchronizations and synchronizations within a predetermined frequency domain (Beta oscillations 15-35 Hz).
The time course of MEG Beta power will be considered, and Granger causal connectivity analyses will be performed to investigate relationships between cortical motor regions.
|
Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Time needed to complete the motor tasks (day 1)
Временное ограничение: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
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The investigators will measure the time needed to complete the motor tasks needed to complete each motor task (finger sequential tasks OR motor adaptation task).
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Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
|
Evidence of MEG correlates of sleep motor consolidation
Временное ограничение: Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
The investigators will use Single Aperture Magnetometry, i.e. a minimum variance beamformer mapping the spatial distribution of event-related desynchronizations and synchronizations within a predetermined frequency domain (Beta oscillations 15-35 Hz).
The time course of MEG Beta power will be considered, and Granger causal connectivity analyses will be performed to investigate relationships between cortical motor regions.
|
Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
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Accuracy of the motor tasks
Временное ограничение: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
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The investigators will measure the number of errors and correct trials for each motor task (finger sequential tasks OR motor adaptation task).
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Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
|
Time needed to complete the motor tasks
Временное ограничение: Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
The investigators will measure the time needed to complete each motor task (finger sequential tasks OR motor adaptation task).
|
Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
Accuracy of the motor tasks 2
Временное ограничение: Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
The investigators will measure the number of errors and correct trials for each motor task (finger sequential tasks OR motor adaptation task).
|
Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Alain NICOLAS, MD, CH Le Vinatier
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 69HCL16_0676
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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