Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-02-28 @ 6:47 PM
Study NCT ID:
NCT02188420
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Finding an Optimal Latency for Paired Associative Stimulation in People With Chronic Stroke
Sponsor:
Organization:
Raw JSON
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5ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Latency Minus 7ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Latency Plus 100ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" + 100ms), known to have no effect, where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cortical Excitability Using Single TMS Pulses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Latency Minus 3ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)'}, {'id': 'OG001', 'title': 'Latency Minus 5ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)'}, {'id': 'OG002', 'title': 'Latency Minus 7ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)'}, {'id': 'OG003', 'title': 'Latency Plus 100ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" + 100ms), known to have no effect, where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.\n\nTranscranial Magnetic Stimulation (Magstim)'}], 'classes': [{'categories': [{'measurements': [{'value': '-.07667', 'spread': '0.06184', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.06164', 'groupId': 'OG001'}, {'value': '-.05667', 'spread': '0.2625', 'groupId': 'OG002'}, {'value': '.1233', 'spread': '0.15173', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.', 'description': 'Assess average size of 20 motor evoked potentials via electromyography (EMG) signal resulting from single TMS pulses to the motor cortex. Measurements taken before and after paired associative stimulation treatment at each session.', 'unitOfMeasure': 'Log10(microvolts)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Randomized Sequence 1) N20-3ms, N20-5ms, N20+100ms, N20-7ms'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Randomized Sequence 2) N20-3ms, N20+100ms, N20-5ms, N20-7ms'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Randomized Sequence 3) N20-7ms, N20-5ms, N20-3ms, N20+100ms'}, {'id': 'FG003', 'title': 'Group 4', 'description': 'Randomized Sequence 4) N20-5ms, N20-3ms, N20-7ms, N20+100ms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There were no significant events or excluded participants prior to being assigned an intervention order'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This is a cross-over study; all participants completed all four treatment arms.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', '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.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2014-06-30', 'resultsFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-04', 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cortical Excitability Using Single TMS Pulses', 'timeFrame': 'Change from pretest (immediately prior to PAS application) to posttest which will occur over the 60 minutes that follow PAS application.', 'description': 'Assess average size of 20 motor evoked potentials via electromyography (EMG) signal resulting from single TMS pulses to the motor cortex. Measurements taken before and after paired associative stimulation treatment at each session.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PAS', 'TMS', 'Stroke', 'Paired Associative Stimulation', 'Transcranial Magnetic Stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'After a stroke, there is an exaggerated inhibitory influence from the non-stroke hemisphere to the stroke hemisphere. Brain stimulation using repetitive transcranial magnetic stimulation (rTMS) to the non-stroke hemisphere can decrease this inhibition. Paired Associative Stimulation (PAS) may be a more effective way to produce this same inhibition, as shown in healthy subjects. However, it is not known whether this will translate to people with stroke. PAS consists of a peripheral nerve stimulus paired a short time later with a cortical stimulus to change the excitability within the brain. Thus the investigators will apply PAS to people with stroke, but the investigators need to first determine the most effective interpulse interval (IPI) between the peripheral and cortical stimuli. Our research question is which of three different IPIs is most effective in changing the excitability of the brain.\n\nThe purpose of this study is to determine the optimal IPI between a peripheral nerve pulse and a cortical stimulus that will be most effective in changing excitability of the brain in people with chronic stroke. The investigators hypothesize that the cortical excitability of the nonstroke hemisphere will be most inhibited with the latency-5ms condition.', 'detailedDescription': 'Numerous PAS studies have been done in healthy subjects and all have been done safely. The proper interpulse interval in healthy individuals between the peripheral nerve stimulus and the cortical stimulus is known to be "latency-5ms." However, this may be different in individuals with stroke.\n\nSpecific Aim: what is the optimal interpulse interval to achieve the maximum inhibitory effect in the nonstroke hemisphere?\n\nWe will recruit three subjects with chronic stroke. Electroencephalography (EEG) will be used to determine the latency between the peripheral nerve stimulus and the sensory evoked potential in each subject. We will then assess the following IPIs on each subject in a random order: "latency" - 3ms, -5ms and -7ms. There will be a fourth condition of "latency" + 100ms (known to have no effect) to be used as a control. The washout period will be at least one week between each of these conditions.\n\nThe optimal IPI will be determined from these tests by comparing single pulse transcranial magnetic stimulation (TMS) measures for cortical excitability. Prior to each treatment, each subject will receive 20 single pulse cortical stimuli to serve as pretest data. The post tests for each condition will consist of 20 single pulse cortical stimuli at 0, 5, 10, 15, 30, 45 and 60 minutes after the PAS condition. Data analysis will consist of a single-subject analysis with the two standard deviation bandwidth method of each post-test compared to pre-test.\n\nWe hypothesize that there will be no adverse advents and that this optimal IPI will be "latency"-5ms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke (ischemic or hemorrhagic) of greater than 6 months duration\n* impairment in the paretic hand\n* over 18 years old\n* male or female\n* on mini mental status exam must have score of 22 or higher\n* must have elicitable motor evoked potential (MEP)\n\nExclusion Criteria:\n\n* seizure within the past two years\n* receptive aphasia\n* epileptogenic medication\n* major psychiatric disorder\n* other interfering comorbidities\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02188420', 'briefTitle': 'Finding an Optimal Latency for Paired Associative Stimulation in People With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Different Interpulse Intervals of Paired Associative Stimulation on Cortical Excitability in People With Chronic Stroke', 'orgStudyIdInfo': {'id': '1406M51743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N20-3ms, N20-5ms, N20+100ms, N20-7ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Wash out period of 1 week then next level will be applied', 'interventionNames': ['Device: Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms)']}, {'type': 'EXPERIMENTAL', 'label': 'N20-5ms, N20-3ms, N20-7ms, N20+100ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Wash out period of 1 week then next level will be applied\n\nLatency minus 7ms Wash out period of 1 week Latency plus 100ms Active comparator', 'interventionNames': ['Device: Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms)']}, {'type': 'EXPERIMENTAL', 'label': 'N20-7ms, N20-5ms, N20-3ms,N20+100ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Wash out period of 1 week then next level will be applied', 'interventionNames': ['Device: ranscranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N20-3ms, N20+100ms, N20-5ms, N20-7ms', 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 100ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG. Wash out period of 1 week', 'interventionNames': ['Device: Transcranial Magnetic Stimulation Time 100ms']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms)', 'type': 'DEVICE', 'otherNames': ['TMS', 'Magstim'], 'description': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 3ms) where "latency" refers to the amount of time for the arrival of a sensory evoked potential as determined by EEG.', 'armGroupLabels': ['N20-3ms, N20-5ms, N20+100ms, N20-7ms']}, {'name': 'Transcranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 5ms)', 'type': 'DEVICE', 'otherNames': ['TMS'], 'description': 'Transcranial Magnetic Stimulation 5ms', 'armGroupLabels': ['N20-5ms, N20-3ms, N20-7ms, N20+100ms']}, {'name': 'ranscranial Magnetic Stimulation will be applied to the primary motor cortex at the interstimulus interval of ("Latency" - 7ms)', 'type': 'DEVICE', 'otherNames': ['TMS'], 'description': 'Transcranial Magnetic Stimulation 7ms', 'armGroupLabels': ['N20-7ms, N20-5ms, N20-3ms,N20+100ms']}, {'name': 'Transcranial Magnetic Stimulation Time 100ms', 'type': 'DEVICE', 'otherNames': ['TMS'], 'description': 'Active Compator', 'armGroupLabels': ['N20-3ms, N20+100ms, N20-5ms, N20-7ms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Clinical and Translational Science Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Kate Frost, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}