Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-21 @ 10:48 AM
Study NCT ID:
NCT02243020
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VNS During Rehabilitation for Improved Upper Limb Motor Function After 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brent@microtransponder.com', 'phone': '5123714160', 'title': 'VP Clinical Affairs', 'organization': 'MicroTransponder Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.\n\nVagus Nerve Stimulation (VNS)', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.\n\nVagus Nerve Stimulation (VNS)", 'otherNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Pain/Bruising from implant surgery', 'notes': 'Pain or bruising from implant surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Wound Infection', 'notes': 'Infection at surgical site that required intravenous antibiotics. The patient recovered and the system remained implanted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath and Dysphagia', 'notes': 'Shortness of breath and dysphagia due to surgical intubation. Subject improved and recovered over several weeks.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hoarseness', 'notes': "Hoarseness after surgery due to nerve manipulation. Subject's voice improved over 12 months but did not recover to 100% (significant improvement but not quite to baseline) after injection and voice therapy.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Upper Extremity Fugl-Meyer (UEFM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.\n\nVagus Nerve Stimulation (VNS)'}, {'id': 'OG001', 'title': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.\n\nVagus Nerve Stimulation (VNS)"}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-weeks', 'description': 'Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Wolf Motor Function Test Functional Assessment (WMFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.\n\nVagus Nerve Stimulation (VNS)'}, {'id': 'OG001', 'title': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.\n\nVagus Nerve Stimulation (VNS)"}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '.13', 'spread': '.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-weeks', 'description': 'Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.\n\nVagus Nerve Stimulation (VNS)'}, {'id': 'FG001', 'title': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.\n\nVagus Nerve Stimulation (VNS)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.\n\nVagus Nerve Stimulation (VNS)'}, {'id': 'BG001', 'title': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.\n\nVagus Nerve Stimulation (VNS)"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time Since Stroke', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '.7', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '.3', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Upper Extremity Fugl-Meyer (UEFM)', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'NOTE: An additional 5 subjects discontinued prior to group assignment. Three (3) discontinued due to investigator exclusion (poor surgical candidate) and two (2) self excluded (time commitment and surgical concerns). This info is as designated by the protocol and FDA device guidelines (subjects consented but were not implanted with the device).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2014-09-15', 'resultsFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-24', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Upper Extremity Fugl-Meyer (UEFM)', 'timeFrame': '6-weeks', 'description': 'Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.'}], 'secondaryOutcomes': [{'measure': 'Change in Wolf Motor Function Test Functional Assessment (WMFT)', 'timeFrame': '6-weeks', 'description': 'Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Upper Limb Deficits']}, 'referencesModule': {'references': [{'pmid': '30355189', 'type': 'RESULT', 'citation': 'Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.'}, {'pmid': '31903435', 'type': 'RESULT', 'citation': 'Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.'}, {'pmid': '31685853', 'type': 'RESULT', 'citation': 'Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.'}, {'pmid': '32476617', 'type': 'DERIVED', 'citation': 'Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior\n2. Age \\>30 years and \\<80 years\n3. Right or left sided weakness of upper extremity\n4. UEFM score within designated range.\n5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits\n\nExclusion Criteria:\n\n1. History of hemorrhagic stroke\n2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.\n3. Significant sensory loss.\n4. Presence of ongoing dysphagia or aspiration difficulties.\n5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.\n6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.\n7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)\n8. Severe depression\n9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)\n10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug\n11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)\n12. Pregnant or plan on becoming pregnant or breastfeeding during the study period\n13. Currently require, or likely to require, diathermy during the study duration\n14. Any health problem requiring surveillance with MRI imaging\n15. Active rehabilitation within 4-weeks prior to therapy\n16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy\n17. Severe spasticity of the upper limb"}, 'identificationModule': {'nctId': 'NCT02243020', 'briefTitle': 'VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroTransponder Inc.'}, 'officialTitle': "Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)", 'orgStudyIdInfo': {'id': 'MT-St-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)', 'description': 'This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.', 'interventionNames': ['Device: Vagus Nerve Stimulation (VNS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'description': "This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.", 'interventionNames': ['Device: Vagus Nerve Stimulation (VNS)']}], 'interventions': [{'name': 'Vagus Nerve Stimulation (VNS)', 'type': 'DEVICE', 'otherNames': ['VNS'], 'armGroupLabels': ['Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator', 'Vagus Nerve Stimulation (VNS) + Rehabilitation (1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Patty Smith, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroTransponder Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}