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Normal PhysiologyNCT04431011

Layer-specific Contribution to Consolidation of Skill Learning in the Primary Motor Cortex

An observational study of Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Training in a new motor skill often involves periods of active practice and periods of rest. During early motor skill learning, improvements in performance usually happen during the short rest periods between practice sessions. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Normal Physiology
How many people
40 participants
Where
1 siteUnited States
Study dates
21 Apr 2021to 9 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Healthy right-handed adults aged 18-50

Who may be able to join

  • Age 18-50
  • English speaking
  • Right-hand dominance (>74 on Edinburgh Handedness Inventory)
  • Normal neurological examination
  • Willing and able to provide informed consent

Who cannot join

  • HCPS-affiliated NIH staff (i.e. - staff from our section).
  • Current pregnancy
  • Current or past history of use of antiepileptic drugs
  • Contraindications for MRI (such as certain implants, metal fragments or devices in the body) as determined by the screening clinician
  • Severe or progressive neurological, psychological or medical condition

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

Training in a new motor skill often involves periods of active practice and periods of rest. During early motor skill learning, improvements in performance usually happen during the short rest periods between practice sessions. Researchers want to use improved imaging techniques to study the contributions of specific parts of the brain to how people learn and retain movement skills.

Read more

Objective:

To learn the part played by different layers in the brain in retaining a newly learned movement skill.

Eligibility:

Healthy, right-handed, English-speaking people age 18-50.

Design:

Participants will be screened with:

  • Medical and neurological history
  • Medicine review
  • Physical exam
  • Neurological exam.

Participants may have 2 magnetic resonance imaging (MRI) scans of the brain. During the MRI, they will lie in the scanner. The scanner makes noise. They will get earplugs.

Participants will have behavior testing. A specific order of keys will be displayed on a computer screen. Participants will practice typing the keys with their left hand 36 times (in 10-second blocks). They will repeat this test with a random order of keys.

Participants will see single numbers displayed one after the other on the computer screen. They will make single tap responses using the finger that corresponds with the number on the screen.

Participants will have up to 4 study sessions. Each session will take about 5 hours.

Read the detailed description

Study Description:

Training on a novel motor skill often involves periods of active practice interspersed with periods of rest. During early motor skill learning, performance improvements develop primarily during short offline rest periods that occur between practice blocks. These performance gains during rest have been referred to as 'micro-offline consolidation'. Primary motor cortex (M1) is a crucial contributor to skill consolidation, however, due to the poor spatial specificity and vascular biases of available imaging methods, the specific neural mechanisms of consolidation in M1 are not known. Recent innovations in functional magnetic resonance imaging (fMRI) have made it possible to measure functional changes across cortical layers. This study will use these techniques to investigate the contributions of specific cortical layers in M1 to motor skill learning and consolidation.

Objectives:

The primary aim is to determine the correlation between activity in superficial M1 cortical layers and behavioral gains during microoffline rest periods. Additionally, we will evaluate the role of superficial and deep cortical layers of M1 in the consolidation of motor skill learning. To address this question, we will measure neural activations across cortical laminae in M1 while participants consolidate a newly acquired motor skill.

Endpoints:

The primary endpoint measures will be: 1) activity in superficial M1 cortical layers during micro-offline rest periods, which will be measured using vascular space occupancy (VASO) MR imaging and 2) behavioral gains during micro-offline rest periods measured as correct sequence typing speed (sequences per second). The secondary endpoint measure will be the ratio of activity between superficial and deep M1 layers during practice and during rest periods compared to pre-learning and to post-learning rest and the localizing random sequence.

Exploratory endpoints will include other fMRI measures that may relate learning with layer activity. For example, we will use multivoxel pattern analysis (MVPA) of activation data to: (a) gain insight into the presence of layer-specific reactivation of sequence task performance during rest periods; and (b) investigate whether this reactivation predicts learning.

Study Population:

45 Healthy participants (18-50 years of age)

Phase:

N/A

Description of Sites/Facilities Enrolling Participants:

This protocol utilizes the NIH Clinical Center Outpatient Clinic, and NMRF core facilities.

Intervention Study Duration:

24 months

Participant Duration:

Approximately 2-5 hours per session, for up to 4 sessions over a 1-4-day time period.

Study Description:

Training on a novel motor skill often involves periods of active practice interspersed with periods of rest. During early motor skill learning, performance improvements develop primarily during short offline rest periods that occur between practice blocks. These performance gains during rest have been referred to as "micro-offline consolidation". Primary motor cortex (M1) is a crucial contributor to skill consolidation; however, due to the poor spatial specificity and vascular biases of available imaging methods, the specific neural mechanisms of consolidation in M1 are not known. Recent innovations in functional magnetic resonance imaging (fMRI) have made it possible to measure functional changes across cortical layers. This study will use these techniques to investigate the contributions of specific cortical layers in M1 to motor skill learning and consolidation.

Keywords
Healthy, Learning Consolidation, Brain, Natural History

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04431011
Study groupRoleWhat they receive
ParticipantsHealthy right-handed participants aged 18-50

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary aim is to determine the role of superficial and deep cortical layers of M1 in the consolidation of motor skill learning.

    To address this question, we will measure neural activations across cortical laminae in M1 while participants consolidate a newly acquired motor skill.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start21 Apr 2021
  3. Primary completion9 Dec 2024
  4. Study completion9 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431011
Sponsor's protocol ID
200105
Other IDs
20-N-0105
Status last verified
18 Sep 2026
First submitted
12 Jun 2020
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary aim is to determine the role of superficial and deep cortical layers of M1 in the consolidation of motor skill learning. (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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