- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511467
Learning in Stroke
Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
INCLUSION CRITERIA
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
- 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)
EXCLUSION CRITERIA
For all participants:
- Presence of any MRI risk factors
- substance use disorder
- psychotic disorders
Stroke-group specific exclusion criteria:
- Primary intracerebral hematoma
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
|
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'.
|
|
stroke group
|
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'.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Pre Learning Session and Post Learning Session (approximately 90 minutes)
|
|
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.
|
Pre Learning Session and Post Learning Session (approximately 90 minutes)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00116626
- 5P20GM109040-10 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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