Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-17 @ 12:19 AM
Study NCT ID:
NCT00683566
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2008-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
State Dependent Resonance in the BG-cortical Loops
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The results are expected to bring further light into the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD and may provide a basis for different therapeutic strategies.', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parkinson'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.", 'detailedDescription': 'Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator. Experiments will be carried out both in the OFF medication and ON medication condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease idiopathic evolving for more than 5 years\n* Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months\n* Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)\n* Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)\n\nExclusion Criteria:\n\n* Patients not verifying the criteria of inclusion\n* Absence of data concerning the location of electrodes"}, 'identificationModule': {'nctId': 'NCT00683566', 'briefTitle': 'State Dependent Resonance in the BG-cortical Loops', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'State Dependent Resonance in the BG-cortical Loops', 'orgStudyIdInfo': {'id': '2007-A01178-45'}, 'secondaryIdInfos': [{'id': '2007 36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'A session in condition ON DOPAMINE and the other one in condition OFF DOPAMINE.', 'interventionNames': ['Procedure: electrostimulation']}], 'interventions': [{'name': 'electrostimulation', 'type': 'PROCEDURE', 'description': 'Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Marseille', 'state': 'Bouches Du Rhone', 'country': 'France', 'facility': 'AP-HM Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'jean philippe AZULAY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}