Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-09 @ 5:14 PM
Study NCT ID:
NCT02850159
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wh.chang@samsung.com', 'phone': '82234102818', 'title': 'Dr. Won Hyuk Chang', 'organization': 'Samsung Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dual-mode Group', 'description': 'the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously\n\nrTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'rTMS Group', 'description': 'high-frequency rTMS and sham tDCS\n\nrTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Freezing of Gait Questionnaire (FOG-Q)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-mode Group', 'description': 'the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously\n\nrTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}, {'id': 'OG001', 'title': 'rTMS Group', 'description': 'high-frequency rTMS and sham tDCS\n\nrTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5', 'description': 'Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dual-mode Group', 'description': 'the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously\n\nrTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}, {'id': 'FG001', 'title': 'rTMS Group', 'description': 'high-frequency rTMS and sham tDCS\n\nrTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dual-mode Group', 'description': 'the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously\n\nrTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}, {'id': 'BG001', 'title': 'rTMS Group', 'description': 'high-frequency rTMS and sham tDCS\n\nrTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Right Handedness', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "32 patients with Parkinson's disease"}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2016-07-22', 'resultsFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-31', 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Freezing of Gait Questionnaire (FOG-Q)', 'timeFrame': 'Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5', 'description': 'Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '28193533', 'type': 'DERIVED', 'citation': 'Chang WH, Kim MS, Park E, Cho JW, Youn J, Kim YK, Kim YH. Effect of Dual-Mode and Dual-Site Noninvasive Brain Stimulation on Freezing of Gait in Patients With Parkinson Disease. Arch Phys Med Rehabil. 2017 Jul;98(7):1283-1290. doi: 10.1016/j.apmr.2017.01.011. Epub 2017 Feb 11.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).", 'detailedDescription': 'Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosed as Parkinson's disease (PD) with freezing of gait\n* walk independently without walking devices\n\nExclusion Criteria:\n\n* pre-existing and active major neurological diseases other than PD\n* a previous history of seizures\n* implanted metallic objects that would contraindicate rTMS"}, 'identificationModule': {'nctId': 'NCT02850159', 'briefTitle': "Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': "Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease", 'orgStudyIdInfo': {'id': '2013-09-122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dual-mode group', 'description': 'the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously', 'interventionNames': ['Device: rTMS and tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rTMS group', 'description': 'high-frequency rTMS and sham tDCS', 'interventionNames': ['Device: rTMS']}], 'interventions': [{'name': 'rTMS and tDCS', 'type': 'DEVICE', 'description': 'Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously', 'armGroupLabels': ['dual-mode group']}, {'name': 'rTMS', 'type': 'DEVICE', 'description': 'Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously', 'armGroupLabels': ['rTMS group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yun-Hee Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}