Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-04 @ 9:10 PM
Study NCT ID:
NCT00142259
Status:
UNKNOWN
Last Update Posted:
2006-12-06
First Post:
2005-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2009-08'}, 'lastUpdateSubmitDate': '2006-12-05', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2006-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline'}], 'secondaryOutcomes': [{'measure': 'relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline'}]}, 'conditionsModule': {'keywords': ['deep brain stimulation', 'internal globus pallidus', 'dystonia'], 'conditions': ['Dystonia']}, 'referencesModule': {'references': [{'pmid': '17093249', 'type': 'RESULT', 'citation': 'Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.'}, {'pmid': '33324891', 'type': 'DERIVED', 'citation': 'Steigerwald F, Kirsch AD, Kuhn AA, Kupsch A, Mueller J, Eisner W, Deuschl G, Falk D, Schnitzler A, Skogseid IM, Vollmer-Haase J, Ip CW, Tronnier V, Vesper J, Naumann M, Volkmann J; DBS study group for dystonia. Evaluation of a programming algorithm for deep brain stimulation in dystonia used in a double-blind, sham-controlled multicenter study. Neurol Res Pract. 2019 Sep 24;1:25. doi: 10.1186/s42466-019-0032-2. eCollection 2019.'}, {'pmid': '23123071', 'type': 'DERIVED', 'citation': 'Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://www.kompetenznetz-parkinson.de', 'label': "Homepage Competence Network on Parkinson's disease sponsored by the German government"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of idiopathic multifocal, segmental or generalised dystonia\n* duration of disease \\> 5 years\n* age between 14 and 75 years\n* relevant disability in activities of daily living despite optimal drug treatment\n* informed consent signed by the patient\n* For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary\n\nExclusion Criteria:\n\n* Mattis-Score \\< 120\n* BDI \\> 25\n* previous stereotactic brain surgery\n* severe brain atrophy\n* increased bleeding risk\n* immunosuppression and increased risk of infection\n* relevant cerebrovascular disease\n* psychiatric disorders, which might interfere with the cooperation in the study\n* other contraindications for surgery'}, 'identificationModule': {'nctId': 'NCT00142259', 'briefTitle': 'Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia', 'organization': {'class': 'OTHER', 'fullName': 'German Parkinson Study Group (GPS)'}, 'officialTitle': 'Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie', 'orgStudyIdInfo': {'id': '15'}, 'secondaryIdInfos': [{'id': 'Grant: 01 GI 0201 / 01 GI 0401'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Deep brain stimulation of the internal globus pallidus', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck, Department of Neurology', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der LMU, Neurologische Klinik', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Neurologische Klinik am Klinikum der BJM-Universität', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Department of Neurology, Charité, Humboldt-University Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Department of Neurology, University Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '24103', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Dept. Neurology, UKSH Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '18147', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Department of Neurology, University Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Jens Volkmann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. Neurology, UKSH Campus Kiel, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Parkinson Study Group (GPS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': "Competence Network on Parkinson's Disease", 'class': 'OTHER'}]}}}