Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00169403
Status:
UNKNOWN
Last Update Posted:
2007-08-29
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2007-08-28', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Idiopathic dystonia', 'deep brain stimulation', 'globus pallidus', 'generalised Idiopathic dystonia'], 'conditions': ['Dystonia']}, 'referencesModule': {'references': [{'pmid': '15689584', 'type': 'RESULT', 'citation': 'Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.'}]}, 'descriptionModule': {'briefSummary': 'Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:\n\n1. evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and\n2. assess the recurrence of the motor symptoms after the switch off.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic generalised dystonia\n* Pallidal stimulation\n\nExclusion Criteria:\n\n* Mini-mental status (MMS) \\< 24\n* Severe psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT00169403', 'briefTitle': 'Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'orgStudyIdInfo': {'id': 'P000201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Deep brain stimulation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Laure Welter, MD', 'role': 'CONTACT', 'email': 'marie-laure.welter@psl.aphp.fr', 'phone': '33-142161950'}, {'name': 'Marie Vidailhet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Marie Vidailhet, MD, PhD', 'role': 'CONTACT', 'email': 'marie.vidailhet@sat.ap-hop-paris.fr', 'phone': '33-142161950'}, {'name': 'Marie-Laure Welter, MD', 'role': 'CONTACT', 'email': 'marie-laure.welter@psl.aphp.fr', 'phone': '33-142161950'}], 'overallOfficials': [{'name': 'Marie Vidailhet, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital Saint-Antoine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Tours', 'class': 'OTHER'}]}}}