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.
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
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.
- Conditions
- Normal Physiology
- 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 group | Role | What they receive |
|---|---|---|
| Participants | Healthy right-handed participants aged 18-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Jun 2020
- Study start21 Apr 2021
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leonardo G Cohen, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Layer-specific Contribution to Consolidation of Skill Learning in the Primary Motor Cortex
- ClinicalTrials.gov ID
- NCT04431011
- Acronym / sponsor ID
- 200105
- Conditions
- Normal Physiology
- Keywords
- Healthy, Learning Consolidation, Brain, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Healthy right-handed participants aged 18-50 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy right-handed adults aged 18-50
Key inclusion criteria (5 listed)
- Age 18-50
- English speaking
- Right-hand dominance (>74 on Edinburgh Handedness Inventory)
- Normal neurological examination
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
To address this question, we will measure neural activations across cortical laminae in M1 while participants consolidate a newly acquired motor skill.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo G Cohen, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
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.