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STN-Stimulation Versus Best Medical Treatment in Advanced PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00196911
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 30, 2006
Information provided by:
German Parkinson Study Group (GPS)

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Implantation of stimulation electrodes in the STN Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2001
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Quality of life
  2. Motor Score in the OFF (UPDRS III)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00196911

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Neurologische Klinik der Charité, Augustenburgerplatz 1
Berlin, Germany, 13353
Neurologische Klinik der Universität, Moorenstr. 5
Düsseldorf, Germany, 40225
Neurologische Klinik der Universität, Neuenheimerfeld 400
Heidelberg, Germany, 69120
Department of Neurology, Schittenhelmstr. 10
Kiel, Germany, 24105
Neurologische Klinik der Universität, Gleuelerstr. 50
Köln, Germany, 50931
Neurologische Klinik der Universität
München, Germany, 81337
Sponsors and Collaborators
German Parkinson Study Group (GPS)
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Principal Investigator: Guenther Deuschl, Prof. Department of Neurology, Christian-Albrechts University
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00196911    
Other Study ID Numbers: A 125/00
Grant 01 GI 0201/01 GI 0401
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: September 2005
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases