Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-22 @ 8:46 PM
Study NCT ID:
NCT02552368
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2015-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Chronic Stroke With IpsiHand
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huskeyt@wustl.edu', 'phone': '314-362-4503', 'title': 'Dr. Thy Huskey', 'organization': 'Washington University School of Medicine - Department of Neurology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Chronic Stroke Survivors', 'description': 'All adverse events were monitored throughout the study completion, an average of 2 years with no events reported.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Action Research Arm Test (ARAT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change in ARAT From Baseline to 12 Weeks of BCI Device Use', 'description': 'IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': "The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, \\& Johnson, 2005).\n\nThe ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:\n\n3\\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty\n\n1\\) Performs test partially 0) Can perform no part of test\n\nThe maximum score achievable on this measure is 57 points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Canadian Occupational Performance Measure (COPM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Change in COPM From Baseline to 12 Weeks of BCI Device Use', 'description': 'Ipsihand is a device that includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.'}], 'classes': [{'title': 'Performance', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Satisfaction', 'categories': [{'measurements': [{'value': '1.54', 'spread': '1.86', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000'], 'groupDescription': 'Signed-Rank Test for Performance COPM between Baseline and 12 weeks', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG000'], 'groupDescription': 'Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': "The COPM is an evidence-based outcome measure designed to capture a client's self-perception of performance in 5 patient-identified tasks over time. Patients identified 5 functional activities that they wanted to perform more independently or with greater ease. COPM measurements consisted of a semi-structured interview in which patients rated their performance \\& satisfaction with each activity on an ordinal scale from 1 to 10. A performance score of 1 indicated they are unable to perform identified task, \\& a score of 10 indicates they are able to complete the functional task as easy as prior to stroke. A satisfaction score of 1 indicated they were not satisfied at all to 10 indicating they are extremely satisfied with how they complete the identified functional task. Patients would rate (5) functional tasks for their performance and satisfaction. Scores were averaged between the scores from the 5 functional activities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IpsiHand', 'description': 'IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.\n\nIpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.\n\nIpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.6', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2015-08-22', 'resultsFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-14', 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Action Research Arm Test (ARAT) Score', 'timeFrame': 'Baseline and 12 weeks', 'description': "The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, \\& Johnson, 2005).\n\nThe ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:\n\n3\\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty\n\n1\\) Performs test partially 0) Can perform no part of test\n\nThe maximum score achievable on this measure is 57 points."}], 'secondaryOutcomes': [{'measure': 'Canadian Occupational Performance Measure (COPM)', 'timeFrame': 'Baseline and 12 weeks', 'description': "The COPM is an evidence-based outcome measure designed to capture a client's self-perception of performance in 5 patient-identified tasks over time. Patients identified 5 functional activities that they wanted to perform more independently or with greater ease. COPM measurements consisted of a semi-structured interview in which patients rated their performance \\& satisfaction with each activity on an ordinal scale from 1 to 10. A performance score of 1 indicated they are unable to perform identified task, \\& a score of 10 indicates they are able to complete the functional task as easy as prior to stroke. A satisfaction score of 1 indicated they were not satisfied at all to 10 indicating they are extremely satisfied with how they complete the identified functional task. Patients would rate (5) functional tasks for their performance and satisfaction. Scores were averaged between the scores from the 5 functional activities."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke Rehabilitation', 'BCI', 'Stroke', 'Upper Extremity Rehabilitation', 'paresis', 'hemiparesis'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '28550098', 'type': 'DERIVED', 'citation': 'Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.', 'detailedDescription': 'This study will be carried out in two phases designed to achieve the objectives described above. The first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. This phase will involve recording EEG signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. After recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. The second phase of the study will determine if the BCI system can be used to impact rehabilitation. Motor commands would be performed as in phase 1 to determine the accompanying EEG signals. The EEG signals would then be used to control stimulation of the impaired limb. Rehabilitation would be assessed by examining changes in commonly used functional motor scores.\n\nThe ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. This ultimate goal will be approached through two different means. The first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. And secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. Finally, the study seeks to assess changes in functional connectivity as a result of using a BCI device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months post stroke\n* Modified Ashworth Scale of 1+ or less of elbow flexion in the affected upper extremity\n* Short Blessed Test Score of 8 or less\n* Unstructured Mesulam with 2 or less omissions\n\nExclusion Criteria:\n\n* Dementia\n* Severe spasticity in affected upper extremity\n* Unilateral Visual Inattention (neglect)\n* Contracture(s) in the affected upper extremity\n* Botox injections administered within 9 months\n* Aphasia which limits effective communication'}, 'identificationModule': {'nctId': 'NCT02552368', 'briefTitle': 'Treatment of Chronic Stroke With IpsiHand', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Brain Computer Interface and Brain-Controlled Stroke Rehabilitation Method Utilizing Electroencephalography in Hemiparetic and Hemiplegic Stroke Patients to Achieve Thought Control of Machines and a Better Understanding of Brain Function', 'orgStudyIdInfo': {'id': '201021771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IpsiHand', 'description': 'IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.', 'interventionNames': ['Device: IpsiHand Device']}], 'interventions': [{'name': 'IpsiHand Device', 'type': 'DEVICE', 'description': 'Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.', 'armGroupLabels': ['IpsiHand']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Thy Huskey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}