Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-27 @ 5:38 AM
Study NCT ID:
NCT03067818
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2017-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D000083242', 'term': 'Ischemic 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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The individual that conducts the tests of arm movement will be unaware of which brain area was stimulated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant will receive stimulation targeting each brain area. The order in which the stimulation sites are targeted for each participant is randomized and there is a washout period of several weeks between each treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-02-24', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in movement time', 'timeFrame': 'Baseline and 1 Day', 'description': 'Percentage change in time it takes to move the arm a standardized distance'}], 'secondaryOutcomes': [{'measure': 'Change in maximum reaching distance', 'timeFrame': 'Baseline and 1 Day', 'description': 'Percentage change in maximum distance participant is able to reach'}, {'measure': 'Change in hand path kinematics', 'timeFrame': 'Baseline and 1 Day', 'description': 'Percentage change in temporal and spatial movement of the hand during reaching'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arm', 'rehabilitation', 'non-invasive brain stimulation', 'transcranial magnetic stimulation', 'upper extremity'], 'conditions': ['Stroke', 'Hemiparesis', 'Cerebral Vascular Accident', 'Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.', 'detailedDescription': 'Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.\n\nTo develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.\n\nThis study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 6 months post-stroke\n* Loss of voluntary finger movement in the affected hand\n* Some voluntary movement of affected shoulder and/or elbow\n\nExclusion Criteria:\n\n* Brainstem or cerebellar stroke\n* Severe cognitive or language deficits\n* Epilepsy or other seizure disorder\n* Central nervous system disease or disorder other than stroke'}, 'identificationModule': {'nctId': 'NCT03067818', 'briefTitle': 'Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis', 'organization': {'class': 'OTHER', 'fullName': 'George Mason University'}, 'officialTitle': 'Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis', 'orgStudyIdInfo': {'id': '1R21HD090516-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD090516-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unaffected Hemisphere', 'description': 'Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice', 'interventionNames': ['Procedure: Unaffected Transcranial Magnetic Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Affected Hemisphere', 'description': 'Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice', 'interventionNames': ['Procedure: Affected Transcranial Magnetic Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Site', 'description': 'Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice', 'interventionNames': ['Procedure: Control Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Unaffected Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'description': 'Non-invasive brain stimulation to unaffected hemisphere site prior to practice', 'armGroupLabels': ['Unaffected Hemisphere']}, {'name': 'Affected Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'description': 'Non-invasive brain stimulation to affected hemisphere site prior to practice', 'armGroupLabels': ['Affected Hemisphere']}, {'name': 'Control Transcranial Magnetic Stimulation', 'type': 'PROCEDURE', 'description': 'Non-invasive brain stimulation to control site prior to practice', 'armGroupLabels': ['Control Site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar National Rehabilitation Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Michelle Harris-Love, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Mason University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Mason University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedStar National Rehabilitation Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}