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The Beneficial Effects of Naps on Motor Learning

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ClinicalTrials.gov Identifier: NCT04312126
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

Memory consolidation is the process by which memories become stable, long-term representations in the brain. Consolidation of a motor skill is dependent upon sleep. Some research shows that daytime naps improve people s motor performance and memory retention. Researchers want to find out how daytime naps may contribute to learning and support consolidation of motor skill memories.

Objective:

To learn the role of memory replay during wakeful rest and sleep (naps) in retaining a newly learned skill.

Eligibility:

English-speaking adults ages 18 and older with chronic stroke, or healthy, right-handed, English-speaking adults ages 18-35 and 50-80

Design:

Participants will be screened with:

  • medical history
  • neurological history
  • medicine review
  • medical exam
  • neurological exam.

Participants will have a magnetic resonance imaging (MRI) scan of the brain. For this, they will lie down in a scanner. The scanner makes loud noises, so they will wear earplugs. They will fill out an MRI screening form before each MRI.

Participants will also have magnetoencephalography (MEG). MEG maps brain activity. It does this by recording the magnetic fields produced by naturally occurring electrical currents in the brain. For MEG, participants will lie down in the MEG room. Their eye movements may be recorded by a video camera.

Participants will have behavior testing. They will practice typing random keys. Then they will repeatedly type a custom sequence that they see on a computer screen. Then they will take a 2-hour nap. Then they will type the same sequence again.

Participants will have no more than 4 visits at the NIH over 3 months. Visits will last 2-4 hours each.


Condition or disease
Stroke

Detailed Description:

Study Description: We will investigate sleep neural replay to motor skill consolidation in three groups: (a) young healthy subjects, (b) older healthy subjects and (c) patients with chronic stroke.

Objective: The primary aim is to determine the relative contribution of neural replay during wakeful rest and sleep to consolidation of a newly learned skill in young and older healthy volunteers, and in chronic stroke patients with magnetoencephalography (MEG). The secondary aim is to evaluate differences in replay rates between these subject cohorts. We will also explore differences in replay rates, spatiotemporal dynamics of neural replay and sleep spindles to generate additional hypotheses and preliminary data for future studies.

Endpoints: The primary endpoint measure is motor skill consolidation (i.e., offline change in correct sequence typing speed following a nap). The secondary endpoint measure is neural replay rate. Exploratory endpoints measures are spatial (i.e. - parcellated source space) and time-frequency maps of neural replay during wakeful rest and sleep, and changes in button-press finger movement kinematics during learning.

Study Population:

Arm 1: 46 healthy young (18-35) volunteers.

Arm 2: 46 healthy older (50-80) volunteers.

Arm 3: 46 chronic (>6 months post-stroke) stroke patients.

Phase: N/A

Descriotion of Site/Facilities: This protocol utilizes the NIH Clinical Center Outpatient Clinic, and NMRF and MEG core facilities.

Intervention: N/A

Study Duration: 48 months

Participant Duration: Up to 4 visits lasting approximately 2-4 hours each.

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Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms Underlying the Beneficial Effects of Naps on Motor Learning
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : December 31, 2024

Group/Cohort
Arm 1
46 healthy young (18-35) volunteers
Arm 2
46 healthy older (50-80) volunteers
Arm 3
46 chronic (>6 months post-stroke) stroke patients



Primary Outcome Measures :
  1. The degree to which motor skill consolidation is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep. [ Time Frame: 4 years ]
    The primary endpoint measure is the degree to which motor skill consolidation (i.e., offline change in correct sequence typing speed) is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep (i.e. multiple regression model with 3 predictors). Exploratory endpoints measures are spatial (i.e. - parcellated source space) and time-frequency maps of neural replay during wakeful rest and sleep.


Secondary Outcome Measures :
  1. Spatial and time-frequency maps of neural replay during wakeful rest and sleep. [ Time Frame: 4 years ]
    The primary endpoint measure is the degree to which motor skill consolidation (i.e., offline change in correct sequence typing speed) is predicted by replay rates during wakeful rest and sleep, and spindle rates during sleep (i.e. multiple regression model with 3 predictors). Exploratory endpoints measures are spatial (i.e. - parcellated source space) and time-frequency maps of neural replay during wakeful rest and sleep.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults 18-35 or 50-80; Stroke patients 18 and older
Criteria
  • HEALTHY VOLUNTEERS:

INCLUSION CRITERIA:

  • Age 18-35 (Arm 1) or 50-80 (Arm 2)
  • English speaking
  • Clear right-hand dominance (>74 on Edinburgh Handedness Inventory)
  • Normal neurological examination as determined by the screening clinician
  • Severe or progressive neurological, psychological or medical condition as determined by the screening clinician.

EXCLUSION CRITERIA:

  • HCPS-section affiliated NIH staff
  • Current pregnancy
  • Contraindications for MRI or MEG.
  • Use of sleep medications within 24 hours of Experimental Session participation

STROKE PATIENTS:

INCLUSION CRITERIA:

  • Age 18 or older
  • Willing and able to provide consent
  • Experienced a stroke 6 months ago or more that affected at least one of the upper extremities at time of stroke diagnosis
  • Ability to perform the study task as assessed during physical examination

EXCLUSION CRITERIA:

  • HCPS-affiliated NIH staff.
  • Current pregnancy
  • History of large stroke in brainstem or cerebellum
  • Severe or progressive neurological disorder other than stroke (e.g., Parkinson s disease or multiple sclerosis)
  • Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, psychiatric, sleep, or endocrine disorders
  • Contraindications for MRI or MEG.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312126


Contacts
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Contact: Margaret K Hayward, C.R.N.P. (301) 451-1335 HCPS.research@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Leonardo G Cohen, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT04312126    
Other Study ID Numbers: 200060
20-N-0060
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 9, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Motor Skill
Sleep
Naps
Neural Replay