Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02704195
Status:
TERMINATED
Last Update Posted:
2016-09-21
First Post:
2016-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2016-03-04', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of Freezing of gait', 'timeFrame': '1 month after new stimulation parameters', 'description': 'the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III,'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Deep brain stimulation', 'Freezing of Gait'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '30826266', 'type': 'DERIVED', 'citation': "Meoni S, Debu B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25."}]}, 'descriptionModule': {'briefSummary': "Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease", 'detailedDescription': "Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.\n\nIn a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent\n\nExclusion Criteria:\n\nPatient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis \\< 130) Other neurologic or medical pathology interfering with gait"}, 'identificationModule': {'nctId': 'NCT02704195', 'acronym': 'STIMSYM', 'briefTitle': 'Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait', 'orgStudyIdInfo': {'id': '2013-A01323-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chronic Subthalamic nucleus stimulation', 'description': 'This arm is the reference, with the best stimulation parameters', 'interventionNames': ['Procedure: Chronic Subthalamic nucleus stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Unilateral reduction of stimulation', 'description': '30% unilateral reduction of Subthalamic nucleus stimulation', 'interventionNames': ['Procedure: Unilateral reduction of stimulation']}], 'interventions': [{'name': 'Unilateral reduction of stimulation', 'type': 'PROCEDURE', 'description': '30% unilateral reduction of Subthalamic nucleus stimulation', 'armGroupLabels': ['Unilateral reduction of stimulation']}, {'name': 'Chronic Subthalamic nucleus stimulation', 'type': 'PROCEDURE', 'description': 'This arm is the reference, with the best stimulation parameters', 'armGroupLabels': ['Chronic Subthalamic nucleus stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Elena Moro, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}