Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT03128567
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2017-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Brain Stimulation for Patients With Parkinson's Disease.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PDQ-39 Quality of life questionnary', 'timeFrame': 'Quality of life one year after surgery', 'description': 'PDQ-39 scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.", 'detailedDescription': 'The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '69 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease\n* disease duration \\> 5 years\n* levodopa related motor complications\n* dopasensitivity \\> 50%\n* signed informed written consent\n* medical social insurance\n\nExclusion Criteria:\n\n* dementia\n* contra-indication to neurosurgery"}, 'identificationModule': {'nctId': 'NCT03128567', 'acronym': 'STTARTLATE', 'briefTitle': "Deep Brain Stimulation for Patients With Parkinson's Disease.", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique', 'orgStudyIdInfo': {'id': 'C 14-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stimulation of the subthalamic nucleus', 'description': "25 patients with Parkinson's disease", 'interventionNames': ['Device: Stimulation of the subthalamic nucleus']}, {'label': 'Best medical treatment', 'description': "25 patients with Parkinson's disease"}], 'interventions': [{'name': 'Stimulation of the subthalamic nucleus', 'type': 'DEVICE', 'description': 'Stimulation of the subthalamic nucleus', 'armGroupLabels': ['Stimulation of the subthalamic nucleus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': "Service d'EFSN, Hôpital Pellegrin", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59037 Lille Cedex', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69677 Bron cedex', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Neurologique Pierre Wertheimer, Service de Neurologie', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021 Poitiers cedex', 'city': 'Poitiers', 'country': 'France', 'facility': 'Service de Neurologie, Pôle Neurosciences, CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059 Toulouse Cedex 9', 'city': 'Toulouse', 'country': 'France', 'facility': "Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. Hôpital Pierre Paul Riquet", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}