Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)

17. června 2021 aktualizováno: Hospices Civils de Lyon

Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice

This study is designed to determine the neural networks underlying the sleep-related motor consolidation process following motor imagery practice. While beneficial effects of sleep are expected for sequential movement but not for adaptation motor tasks, the corresponding neuroanatomical correlates have not yet been investigated when participants acquired the motor tasks through mental practice. Data should substantially promote how designing motor imagery interventions targeting (re)learning and/or motor recovery in patients suffering from motor disorders.

Přehled studie

Typ studie

Intervenční

Zápis (Aktuální)

51

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Bron, Francie, 69500
        • CH Le Vinatier

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 40 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

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

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alain NICOLAS, MD, CH Le Vinatier

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

9. prosince 2015

Primární dokončení (Aktuální)

9. prosince 2017

Dokončení studie (Aktuální)

4. července 2018

Termíny zápisu do studia

První předloženo

10. března 2017

První předloženo, které splnilo kritéria kontroly kvality

21. dubna 2017

První zveřejněno (Aktuální)

26. dubna 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. června 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. června 2021

Naposledy ověřeno

1. června 2021

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

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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

3
Předplatit