Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 2:45 PM
Study NCT ID:
NCT03442868
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2018-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-invasive Brain Stimulation (NIBS) and Dual-task Walking 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HGoh1@twu.edu', 'phone': '2146897723', 'title': 'Hui-Ting Goh', 'organization': "Texas Woman's University"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': '1 participant reported mild headache after stimulation. The headache was resolved about 2 hours after the session ended.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': '1 participant was admitted to the hospital between the1st and the 2nd visit due to a lung infection.\n\nThe event was deemed unrelated to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Gait Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'classes': [{'title': 'Primary motor cortex (M1)', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Supplementary motor area (SMA)', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '2.64', 'groupId': 'OG000'}]}]}, {'title': 'Dorsolateral prefrontal cortex (DLPFC)', 'categories': [{'measurements': [{'value': '5.49', 'spread': '2.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'gait speed in m/s will be captured using GaitRite gait assessment walkway', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in gait speed under the dual-task conditions were compared across the 3 visits.'}, {'type': 'SECONDARY', 'title': 'Change in Step Lengths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'classes': [{'title': 'Changes in R step length after rTMS to DLPFC', 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Changes in L step length after rTMS to DLPFC', 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in right (R) and left (L) step lengths after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC)'}, {'type': 'SECONDARY', 'title': 'Change in Single Support Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'classes': [{'title': 'changes in R single support after rTMS to DLPFC', 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.87', 'groupId': 'OG000'}]}]}, {'title': 'changes in L single support after rTMS', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway', 'unitOfMeasure': 'percentage of gait cycle', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in right (R) and left (L) single support time after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC)'}, {'type': 'SECONDARY', 'title': 'Change in Counting Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'classes': [{'title': 'Primary motor cortex (M1)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Supplementary motor area (SMA)', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Dorsolateral prefrontal cortex (DLPFC)', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'number of correct responses in counting backward task', 'unitOfMeasure': 'number of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'number of correct response under the dual-task conditions before and after the rTMS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from Dallas Fort Worth metro area. Recruitment started in October 2016 and last participant was enrolled in Oct 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'High Frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.\n\nhigh frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '9.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-19', 'size': 725875, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-06T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2018-02-09', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-19', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gait Speed', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'gait speed in m/s will be captured using GaitRite gait assessment walkway'}], 'secondaryOutcomes': [{'measure': 'Change in Step Lengths', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway'}, {'measure': 'Change in Single Support Times', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway'}, {'measure': 'Change in Counting Task Performance', 'timeFrame': 'before and 10 minutes after the non-invasive brain stimulation', 'description': 'number of correct responses in counting backward task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.', 'detailedDescription': 'This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age above 18 years\n2. Diagnosis of Left hemispheric stroke at least 6 months ago\n3. First time stroke OR complete gait recovery from prior stroke\n4. Able to walk independently for at least 10 meters with or without walking aids\n5. Have at least minimal movements (\\> 5 degree of motion) at the affected ankle\n6. Score \\> 26 on Mini Mental State Exam (MMSE)\n7. Ability to participate in the informed consent process\n\nExclusion Criteria:\n\n1. Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis\n2. Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)\n3. Unstable clinical conditions\n4. Non-ambulatory prior to onset of stroke\n5. History of significant head trauma\n6. Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip\n7. Metal implantation in the oral cavity, head/neck area and lower extremity\n8. Pregnancy\n9. History of seizures or unexplained loss of consciousness\n10. Immediate family member with epilepsy\n11. Use of seizure threshold lowering medicine\n12. Current abuse of alcohol or drugs\n13. Anticipated inability to complete the study\n14. History of psychiatric illness requiring medication control'}, 'identificationModule': {'nctId': 'NCT03442868', 'briefTitle': 'Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study', 'orgStudyIdInfo': {'id': '19219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High frequency rTMS', 'description': 'High frequency rTMS will be applied to different neural loci based on the randomized sessions.', 'interventionNames': ['Device: high frequency rTMS']}], 'interventions': [{'name': 'high frequency rTMS', 'type': 'DEVICE', 'description': 'Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex (M1), supplementary motor area (SMA) and dorsolateral prefrontal cortex (DLPFC) at different sessions. Walking performance is evaluated before and after the brain stimulation.', 'armGroupLabels': ['High frequency rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Woman's University", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Hui-Ting Goh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Woman's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hui Ting Goh', 'investigatorAffiliation': "Texas Woman's University"}}}}