Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT01905995
Status:
UNKNOWN
Last Update Posted:
2013-07-23
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basal Ganglia Local Field Potentials in Gait and Speech
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-22', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of frequency spectrum of basal ganglia local field potentials during gait and speech', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Evidence for the benefit of different stimulator settings for gait and speech', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep brain sitimulation', 'local field potentials'], 'conditions': ['Basal Ganglia Diseases']}, 'descriptionModule': {'briefSummary': 'Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc).\n\nStudy hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with advanced Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good levodopa response\n\nExclusion Criteria:\n\n* dementia'}, 'identificationModule': {'nctId': 'NCT01905995', 'briefTitle': 'Basal Ganglia Local Field Potentials in Gait and Speech', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': "Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'BG EEG Munich'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients with advanced Parkinson's disease", 'description': 'no intervention - observational study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich/München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kai Bötzel, M.D.', 'role': 'CONTACT', 'email': 'kboetzel@med.uni-muenchen.de', 'phone': '0049 89 7095 3673'}, {'name': 'Kai Bötzel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Neurology, Ludwig-Maximilians University of Munich'}], 'centralContacts': [{'name': 'Kai Boetzel, M.D', 'role': 'CONTACT', 'email': 'kboetzel@med.uni-muenchen.de', 'phone': '00498970953673'}], 'overallOfficials': [{'name': 'Kai Bötzel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Maximilians - University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kai Bötzel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Lueneburg Heritage', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.', 'investigatorFullName': 'Kai Bötzel', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}