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STN-Stimulation Versus Best Medical Treatment in Advanced PD

This study has been completed.
Information provided by:
German Parkinson Study Group (GPS) Identifier:
First received: September 11, 2005
Last updated: November 29, 2006
Last verified: September 2005
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
Parkinson's Disease
Procedure: Implantation of stimulation electrodes in the STN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by German Parkinson Study Group (GPS):

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

Estimated Enrollment: 156
Study Start Date: January 2001
Estimated Study Completion Date: January 2005
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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00196911

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)
Principal Investigator: Guenther Deuschl, Prof. Department of Neurology, Christian-Albrechts University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00196911     History of Changes
Other Study ID Numbers: A 125/00
Grant 01 GI 0201/01 GI 0401
Study First Received: September 11, 2005
Last Updated: November 29, 2006

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on April 28, 2017