- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03130322
SLeep and IMagery Correlates (SOMMEIL-IMAGERIE)
Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Bron, Frankreich, 69500
- CH Le Vinatier
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
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Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Evidence of MEG correlates of sleep motor consolidation (day 1)
Zeitfenster: 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)
Zeitfenster: Day 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (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 2 at 9h00 [Retention test] (Groups 1, 2 and 3) OR Day 1 at 19h00 [Retention test] (Group 4)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time needed to complete the motor tasks (day 1)
Zeitfenster: 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)
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Evidence of MEG correlates of sleep motor consolidation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Alain NICOLAS, MD, CH Le Vinatier
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 69HCL16_0676
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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