Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT05511467
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Learning in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heisek@musc.edu', 'phone': '(843) 792-3435', 'title': 'Principal Investigator', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the duration of the experimental procedures (approximately 4 individual visits within 2 consecutive weeks).', 'description': 'Adverse events were defined as unexpected events during experimental procedures, specifically including magnetic resonance imaging (MRI), related or unrelated to experimental procedures.', 'eventGroups': [{'id': 'EG000', 'title': 'stroke group', 'description': "Visuomotor learning task: 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'.", 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'control group', 'description': "Visuomotor learning task: 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'.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Incidental finding during MRI', 'notes': 'Incidental finding during magnetic resonance imaging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'stroke group', 'description': "Visuomotor learning task: 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'."}, {'id': 'OG001', 'title': 'control group', 'description': "Visuomotor learning task: 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'."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.48', 'groupId': 'OG000', 'lowerLimit': '-72.6', 'upperLimit': '45.9'}, {'value': '0.303', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '12.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre Learning Session and Post Learning Session (approximately 90 minutes)', 'description': 'Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction.\n\nPrecision 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.', 'unitOfMeasure': 'Percentage deviation from target force', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One stroke group participant was excluded because of poor data quality (excessive movement inside the MRI). One control group participant excluded due to incidental findings.'}, {'type': 'PRIMARY', 'title': 'Change in Blood-oxygen-level-dependent (BOLD) Signal Derived Multi-voxel Brain Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'stroke group', 'description': "Visuomotor learning task: 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'."}, {'id': 'OG001', 'title': 'control group', 'description': "Visuomotor learning task: 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'."}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.2'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre Learning Session and Post Learning Session (approximately 90 minutes)', 'description': 'Learning-related BOLD-signal-derived brain activation relative to motor performance.', 'unitOfMeasure': 'percentage of BOLD signal change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One stroke group participant was excluded because of poor data quality (excessive movement inside the MRI). One control group participant excluded due to incidental findings.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'stroke group', 'description': "Visuomotor learning task: 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'."}, {'id': 'FG001', 'title': 'control group', 'description': "Visuomotor learning task: 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'."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period 09/01/2022 - 03/30/2024'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'stroke group', 'description': "Visuomotor learning task: 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'."}, {'id': 'BG001', 'title': 'control group', 'description': "Visuomotor learning task: 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'."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '77'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '77'}, {'value': '59.5', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-14', 'size': 813294, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-12T12:51', 'hasProtocol': True}, {'date': '2021-12-23', 'size': 322440, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-01T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2022-08-09', 'resultsFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2022-08-20', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-14', 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment)', 'timeFrame': 'Pre Learning Session and Post Learning Session (approximately 90 minutes)', 'description': 'Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction.\n\nPrecision 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.'}, {'measure': 'Change in Blood-oxygen-level-dependent (BOLD) Signal Derived Multi-voxel Brain Activation', 'timeFrame': 'Pre Learning Session and Post Learning Session (approximately 90 minutes)', 'description': 'Learning-related BOLD-signal-derived brain activation relative to motor performance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['procedural learning', 'maladaptive plasticity'], 'conditions': ['Stroke', 'Sensorimotor Impairment']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke survivors (\\>6 months) after their index lesion, ≥18 years of age. Healthy adults (≥18 years of age).', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nFor all participants:\n\n* adult volunteers (age ≥18 years)\n* right-hand dominance as defined by the Edinburgh Handedness Inventory\n\nStroke-specific inclusion criteria:\n\n* ischemic or hemorrhagic lesion\n* subcortical or cortical tissue involvement\n* chronic phase (\\>6 months) after their index lesion\n* voluntary whole-hand grip force (MRC, Medical Research Council scale for muscle force ≥2)\n* repeated release (standardized as a reduction of 50% of maximum voluntary contraction measured with a dynamometer)\n\nEXCLUSION CRITERIA\n\nFor all participants:\n\n* Presence of any MRI risk factors\n* substance use disorder\n* psychotic disorders\n\nStroke-group specific exclusion criteria:\n\n* Primary intracerebral hematoma\n* subarachnoid hemorrhage\n* bi-hemispheric or cerebellar strokes\n* other concomitant neurological disorders affecting upper extremity motor function\n* documented history of dementia before or after stroke\n* severe aphasia, particularly of receptive nature (NIHSS Language subsection ≥2), affecting their ability to understand the purpose of the study and give informed consent\n* uncontrolled hypertension despite treatment\n* intake of tricyclic anti-depressants or neuroleptic medication.'}, 'identificationModule': {'nctId': 'NCT05511467', 'briefTitle': 'Learning in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Neural Circuitries of Motor Learning as a Target to Modulate Sensorimotor Recovery After Stroke', 'orgStudyIdInfo': {'id': '00116626'}, 'secondaryIdInfos': [{'id': '5P20GM109040-10', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM109040-10', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'stroke group', 'interventionNames': ['Behavioral: Visuomotor learning task']}, {'label': 'control group', 'interventionNames': ['Behavioral: Visuomotor learning task']}], 'interventions': [{'name': 'Visuomotor learning task', 'type': 'BEHAVIORAL', 'description': "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'.", 'armGroupLabels': ['control group', 'stroke group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}