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Sponsored by: |
German Parkinson Study Group (GPS) |
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Information provided by: | German Parkinson Study Group (GPS) |
ClinicalTrials.gov Identifier: | NCT00196911 |
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Procedure: Implantation of stimulation electrodes in the STN |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment |
Estimated Enrollment: | 156 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | January 2005 |
Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2
Exclusion Criteria:
age>75 years depression psychosis surgical contraindications
Germany | |
Department of Neurology, Schittenhelmstr. 10 | |
Kiel, Germany, 24105 | |
Neurologische Klinik der Universität | |
München, Germany, 81337 | |
Neurologische Klinik der Charité, Augustenburgerplatz 1 | |
Berlin, Germany, 13353 | |
Neurologische Klinik der Universität, Neuenheimerfeld 400 | |
Heidelberg, Germany, 69120 | |
Neurologische Klinik der Universität, Gleuelerstr. 50 | |
Köln, Germany, 50931 | |
Neurologische Klinik der Universität, Moorenstr. 5 | |
Düsseldorf, Germany, 40225 |
Principal Investigator: | Guenther Deuschl, Prof. | Department of Neurology, Christian-Albrechts University |
Study ID Numbers: | A 125/00, Grant 01 GI 0201/01 GI 0401 |
Study First Received: | September 11, 2005 |
Last Updated: | November 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00196911 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases Quality of Life |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |