Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00221793
Status:
COMPLETED
Last Update Posted:
2008-09-18
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
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': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.', 'timeFrame': 'After surgery and at 3 months'}], 'secondaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': 'At visit 1 and at 3 months'}, {'measure': 'increase of energy intake', 'timeFrame': 'At visit 1 and at 3 months'}, {'measure': 'leptin, glucose, insulin blood levels', 'timeFrame': 'At visite 1 and at 3 months'}, {'measure': 'cognitive and psychological assessments', 'timeFrame': 'before surgery and after 3 months'}, {'measure': 'UDPRS scale', 'timeFrame': 'before surgery and after 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson', 'deep subthalamic stimulation', 'pharmacological treatment'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.', 'detailedDescription': 'The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.\n\nTwenty parkinsonian patients will be randomised : the delay between inclusion and neurostimulation wil be lengthened 3 months for one group, compared to the second one. The energy expenditure, at rest and after ingestion of a test meal, will be compared between the group of patients that had been neurostimulated and the group whose intervention has been postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be compared between both groups, and the nature and repartition of the weight gain will be assessed in the neurostimulated group. An eventual link between motor factors, pharmacological factors, and gain weight will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years.\n\nExclusion Criteria:\n\n* diabetes thyroid disease pacemaker coagulation troubles previous drug abuse'}, 'identificationModule': {'nctId': 'NCT00221793', 'briefTitle': 'Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus', 'orgStudyIdInfo': {'id': '9212-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Deep Brain Stimulation of the Subthalamic Nucleus', 'interventionNames': ['Procedure: Deep brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Later Deep Brain Stimulation of the Subthalamic Nucleus', 'interventionNames': ['Procedure: Deep brain stimulation']}], 'interventions': [{'name': 'Deep brain stimulation', 'type': 'PROCEDURE', 'description': 'Brain Stimulation of the Subthalamic Nucleus', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Service de neurologie Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'François TISON, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de neurologie Hôpital Haut-Lévêque Pessac'}, {'name': 'Jacques DEMOTES-MAINARD, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'CIC Inserm-CHU de Bordeaux Pessac'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY / Clinical Research and Innovation Director', 'oldOrganization': 'University Hospital, Bordeaux'}}}}