StrokeNCT05511467
Learning in Stroke
An observational study of Stroke and Sensorimotor Impairment, run by Medical University of South Carolina at 1 site in United States.
Trial summary
After a stroke, plasticity occurs in the brain from microscopic to network level with positive but also negative consequences for functional recovery. Why post-stroke plasticity takes a beneficial or a maladaptive direction is still incompletely understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Sensorimotor Impairment
- What is being tested?
- Visuomotor learning task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke survivors (>6 months) after their index lesion, ≥18 years of age. Healthy adults (≥18 years of age).
Who may be able to join
- For all participants:
- adult volunteers (age ≥18 years)
- right-hand dominance as defined by the Edinburgh Handedness Inventory
- Stroke-specific inclusion criteria:
- ischemic or hemorrhagic lesion
- subcortical or cortical tissue involvement
Show all 9Show fewer
- chronic phase (>6 months) after their index lesion
- voluntary whole-hand grip force (MRC, Medical Research Council scale for muscle force ≥2)
- repeated release (standardized as a reduction of 50% of maximum voluntary contraction measured with a dynamometer)
Who cannot join
- For all participants:
- Presence of any MRI risk factors
- substance use disorder
- psychotic disorders
- Stroke-group specific exclusion criteria:
- Primary intracerebral hematoma
Show all 13Show fewer
- subarachnoid hemorrhage
- bi-hemispheric or cerebellar strokes
- other concomitant neurological disorders affecting upper extremity motor function
- documented history of dementia before or after stroke
- severe aphasia, particularly of receptive nature (NIHSS Language subsection ≥2), affecting their ability to understand the purpose of the study and give informed consent
- uncontrolled hypertension despite treatment
- intake of tricyclic anti-depressants or neuroleptic medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
After a stroke, plasticity occurs in the brain from microscopic to network level with positive but also negative consequences for functional recovery. Why post-stroke plasticity takes a beneficial or a maladaptive direction is still incompletely understood. Because the biological mechanisms underlying sensorimotor learning parallel those observed during recovery, learning mechanisms could be potential modifiers of post-stroke neuroplasticity and have a discrete mal-/adaptive impact on the recovery of sensorimotor function. This project seeks to further the understanding of the link between brain circuits that control the integration of new information during procedural learning in the injured brain and those circuits that are involved in adaptive plastic changes during recovery of sensorimotor function post-stroke. The project's methodological approach will allow the characterization of procedural learning-related neural network dynamics based on functional magnetic resonance imaging (MRI) in human volunteers with and without neurologically impairment post-stroke. Through multivariate integration of behavioral and biological descriptors of sensorimotor recovery, the project will investigate the association between motor learning-related network dynamics and descriptors of recovery.
- Conditions
- Stroke, Sensorimotor Impairment
- Being tested
- Visuomotor learning task
- Keywords
- procedural learning, maladaptive plasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuomotor learning taskBehavioural
Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
| Study group | Role | What they receive |
|---|---|---|
| stroke group | Not described Receives: Behavioral: Visuomotor learning task | |
| control group | Not described Receives: Behavioral: Visuomotor learning task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment)
Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction.
Precision of force adjustment is based on the recorded muscle force monitored during task performance and defined as the actual force exerted by the participant relative to the target force (measurement unit: precision in %), with positive values indicating over- and negative values indicating undershoot. Learning rate from before to after learning will be defined as the difference in precision between before as compared to after one single learning session. Precision error was calculated as the percentage deviation of the actual grip force from the target force, averaged across trials before and after the learning task. A reduction in force error indexes a behavioral advantage of force adjustment over time and is thus interpreted as learning.
Measured: Pre Learning Session and Post Learning Session (approximately 90 minutes)
Change in Blood-oxygen-level-dependent (BOLD) Signal Derived Multi-voxel Brain Activation
Learning-related BOLD-signal-derived brain activation relative to motor performance.
Measured: Pre Learning Session and Post Learning Session (approximately 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Mar 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511467
- Sponsor's protocol ID
- 00116626
- Other IDs
- 5P20GM109040-10
- Status last verified
- Oct 2025
- First submitted
- 9 Aug 2022
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05511467
- Acronym / sponsor ID
- 00116626
- Conditions
- Stroke, Sensorimotor Impairment
- Keywords
- procedural learning, maladaptive plasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After a stroke, plasticity occurs in the brain from microscopic to network level with positive but also negative consequences for functional recovery. Why post-stroke plasticity takes a beneficial or a maladaptive direction is still incompletely understood. Because the biological mechanisms underlying sensorimotor learning parallel those observed during recovery, learning mechanisms could be potential modifiers of post-stroke neuroplasticity and have a discrete mal-/adaptive impact on the recovery of sensorimotor function. This project seeks to further the understanding of the link between brain circuits that control the integration of new information during procedural learning in the injured brain and those circuits that are involved in adaptive plastic changes during recovery of sensorimotor function post-stroke. The project's methodological approach will allow the characterization of procedural learning-related neural network dynamics based on functional magnetic resonance imaging (MRI) in human volunteers with and without neurologically impairment post-stroke. Through multivariate integration of behavioral and biological descriptors of sensorimotor recovery, the project will investigate the association between motor learning-related network dynamics and descriptors of recovery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Behavioral: Visuomotor learning task |
| control group | – | Behavioral: Visuomotor learning task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors (>6 months) after their index lesion, ≥18 years of age. Healthy adults (≥18 years of age).
Key inclusion criteria (9 listed)
- adult volunteers (age ≥18 years)
- right-hand dominance as defined by the Edinburgh Handedness Inventory
- ischemic or hemorrhagic lesion
- subcortical or cortical tissue involvement
- chronic phase (>6 months) after their index lesion
Key exclusion criteria (13 listed)
- Presence of any MRI risk factors
- substance use disorder
- psychotic disorders
- Primary intracerebral hematoma
- subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuomotor learning taskParticipants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'. | Behavioural | control group, stroke group |
Primary outcome
Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment)
Time frame: Pre Learning Session and Post Learning Session (approximately 90 minutes)
Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction. Precision of force adjustment is based on the recorded muscle force monitored during task performance and defined as the actual force exerted by the participant relative to the target force (measurement unit: precision in %), with positive values indicating over- and negative values indicating undershoot. Learning rate from before to after learning will be defined as the difference in precision between before as compared to after one single learning session. Precision error was calculated as the percentage deviation of the actual grip force from the target force, averaged across trials before and after the learning task. A reduction in force error indexes a behavioral advantage of force adjustment over time and is thus interpreted as learning.
Change in Blood-oxygen-level-dependent (BOLD) Signal Derived Multi-voxel Brain Activation
Time frame: Pre Learning Session and Post Learning Session (approximately 90 minutes)
Learning-related BOLD-signal-derived brain activation relative to motor performance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke and Sensorimotor Impairment, run by Medical University of South Carolina 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 9 inclusion and 13 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 20 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment) (time frame: Pre Learning Session and Post Learning Session (approximately 90 minutes)). The study lists 2 primary outcomes in all. 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 20 Oct 2025.