Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
Study NCT ID:
NCT04449068
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2020-06-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Database on Deep Brain Stimulation in Tourette Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'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': 'D013981', 'term': 'Tic Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2031-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the severity of tics', 'timeFrame': 'Month 60', 'description': 'Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) .\n\nThe overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bilateral deep brain stimulation', 'Tourette syndrome,'], 'conditions': ['Tourette Syndrome']}, 'referencesModule': {'references': [{'pmid': '28645853', 'type': 'BACKGROUND', 'citation': "Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20."}, {'pmid': '30788865', 'type': 'BACKGROUND', 'citation': "Welter ML, Houeto JL, Worbe Y, Diallo MH, Hartmann A, Tezenas du Montcel S, Ansquer S, Thobois S, Fontaine D, Rouaud T, Cuny E, Karachi C, Mallet L; STIC study group. Long-term effects of anterior pallidal deep brain stimulation for tourette's syndrome. Mov Disord. 2019 Apr;34(4):586-588. doi: 10.1002/mds.27645. Epub 2019 Feb 20. No abstract available."}]}, 'descriptionModule': {'briefSummary': 'Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.', 'detailedDescription': 'Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On average, three to four patients undergo surgery every year. Even though a first follow-up of the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once yearly after surgery until reaching the 5-year mark. The investigator team hopes these data may help to plan for future international multicenter trials, and provide indications on prognostic factors concerning response to GPi DBS in TS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Tourette syndrome eligible for bilateral deep brain stimulation of the anterior internal pallid globus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation\n* Person who voluntarily and knowledgeably agreed to participate in the study\n\nExclusion Criteria:\n\n* Non affiliation to a French social security system (recipient or assign) excluding AME'}, 'identificationModule': {'nctId': 'NCT04449068', 'acronym': 'POSTSTIC', 'briefTitle': 'Observational Database on Deep Brain Stimulation in Tourette Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pre et Post-operative Evaluation of Patients With Tourette Syndrome Treated With High Frequency Bilateral Stimulation of the Anterior Part of the Internal Pallid Globus', 'orgStudyIdInfo': {'id': 'APHP190808'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Evaluation of patients with Tourette's Gilles Syndrome", 'description': "Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus", 'interventionNames': ['Other: Neurological and neuropsychological Follow-up after deep brain stimulation']}], 'interventions': [{'name': 'Neurological and neuropsychological Follow-up after deep brain stimulation', 'type': 'OTHER', 'description': 'Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)', 'armGroupLabels': ["Evaluation of patients with Tourette's Gilles Syndrome"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Andres Hartmann, MD', 'role': 'CONTACT', 'email': 'andreas.hartmann@aphp.fr', 'phone': '01 42 16 13 16', 'phoneExt': '+33'}], 'facility': 'CIC Neurosciences, GH Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Andreas HARTMANN, MD', 'role': 'CONTACT', 'email': 'andreas.hartmann@aphp.fr', 'phone': '1 42 16 13 16', 'phoneExt': '+33'}, {'name': 'Yulia Worbe, MD,PHD', 'role': 'CONTACT', 'email': 'yulia.worbe@aphp.fr', 'phone': '142161316', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}