- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03130322
SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)
Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Bron, Francie, 69500
- CH Le Vinatier
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
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.
|
Experimentální: 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.
|
Experimentální: 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.
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Evidence of MEG correlates of sleep motor consolidation (day 1)
Časové okno: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (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 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 (day 2)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time needed to complete the motor tasks (day 1)
Časové okno: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (Group 4)
|
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).
|
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
Časové okno: 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)
|
Accuracy of the motor tasks
Časové okno: Day 1 at 19h00 [post-training] (Groups 1, 2 and 3) OR Day 1 at 9h00 [post-training] (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 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Alain NICOLAS, MD, CH Le Vinatier
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 69HCL16_0676
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Zdravý
-
University of ZurichDokončenoOutcome Assessment, Health CareŠvýcarsko
-
University of BernUniversity Hospital Inselspital, BerneDokončenoNeuroscience of Dreaming, HealthŠvýcarsko
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciAktivní, ne náborPreventivní zdravotní služby (PREV HEALTH SERV)Spojené státy
-
Queens College, The City University of New YorkNáborZveřejnění článků předložených American Journal of Public HealthSpojené státy
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsDokončenoBolest | Užívání opioidů | Totální náhrada kolena | Aplikace E-healthHolandsko
-
Istanbul University - Cerrahpasa (IUC)NáborKardiochirurgie, Srdeční chirurgie, Výuka propouštění, Ošetřovatelství, Telenutriční péče, m-Health, Kvalita života, ZotaveníKrocan
-
FIDMAG Germanes HospitalàriesUniversity of BarcelonaZatím nenabírámePorucha duševního zdraví | Duševní zdraví wellness 1 | Role sestry | Care Acceptor, Health | Vztah, sestra pacienta
-
University of AarhusRegion MidtJylland Denmark; Tryg Danmark; Randers Municipality, DenmarkNeznámýKardiovaskulární onemocnění | Podpora zdraví | Duševní zdraví | Fyzická nečinnost | Self-reported Quality of HealthDánsko
-
Yorkshire Ambulance Service NHS TrustUniversity of BradfordZatím nenabírámeTestování Point of Care | Klinické rozhodování | Komunitní urgentní a pohotovostní péče | Allied Health Professional
-
4Life Research, LLCDokončenoSin Health | Hydratace pleti | Kožní vrásky | Kožní porfyriny | Červené skvrny na kůži obličeje | Červená vaskulatura kůže obličejeSpojené státy