NCT04312126

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2021Aug 2026

First Submitted

Initial submission to the registry

March 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 20, 2025

Status Verified

August 12, 2025

Enrollment Period

5.4 years

First QC Date

March 14, 2020

Last Update Submit

August 19, 2025

Conditions

Keywords

Motor SkillSleepNeural ReplayNatural History

Outcome Measures

Primary Outcomes (1)

  • 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 r...

    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).

    4 years

Secondary Outcomes (1)

  • Exploratory endpoints measures are spatial (i.e. - parcellated source space) and time-frequency maps of neural replay during wakeful rest and sleep.

    4 years

Study Arms (3)

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

Device: MRI systemDevice: MEG system

Interventions

MRI system - GE Discovery MR750 3T

Arm 3

MEG system The CTF MEG 275 Magnetoencephalography (MEG) scanner system

Arm 3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Right-handed adults between the ages of 18 and 80.

You may qualify if:

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

You may not qualify if:

  • HCPS affiliated NIH staff (i.e. - staff from our section).
  • Current pregnancy.
  • Contraindications for MRI or MEG.
  • Use of sleep medications within 24 hours of Experimental Session participation.
  • Severe or progressive neurological, psychological or medical condition as determined by the screening clinician.
  • STROKE PATIENTS:
  • 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
  • English-speaking
  • HCPS-affiliated NIH staff (i.e. - staff from our section).
  • Current pregnancy
  • History of large stroke lesions in brainstem or cerebellum as determined by screening clinician
  • Severe or progressive neurological disorder other than stroke (e.g., Parkinson s disease or multiple sclerosis) as determined by the screening clinician
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Leonardo G Cohen, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasneem F Malik, C.R.N.P.

CONTACT

Leonardo G Cohen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 18, 2020

Study Start

March 4, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08-12

Locations