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SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)

17 juni 2021 bijgewerkt door: 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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

51

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Bron, Frankrijk, 69500
        • CH Le Vinatier

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Experimenteel: 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.
Experimenteel: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evidence of MEG correlates of sleep motor consolidation (day 1)
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time needed to complete the motor tasks (day 1)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Alain NICOLAS, MD, CH Le Vinatier

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 december 2015

Primaire voltooiing (Werkelijk)

9 december 2017

Studie voltooiing (Werkelijk)

4 juli 2018

Studieregistratiedata

Eerst ingediend

10 maart 2017

Eerst ingediend dat voldeed aan de QC-criteria

21 april 2017

Eerst geplaatst (Werkelijk)

26 april 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2021

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2021

Laatst geverifieerd

1 juni 2021

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 69HCL16_0676

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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