STN-Stimulation Versus Best Medical Treatment in Advanced PD

This study has been completed.
Sponsor:
Information provided by:
German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:
NCT00196911
First received: September 11, 2005
Last updated: November 29, 2006
Last verified: September 2005

September 11, 2005
November 29, 2006
January 2001
Not Provided
  • Quality of life
  • Motor Score in the OFF (UPDRS III)
Same as current
Complete list of historical versions of study NCT00196911 on ClinicalTrials.gov Archive Site
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STN-Stimulation Versus Best Medical Treatment in Advanced PD
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Procedure: Implantation of stimulation electrodes in the STN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
January 2005
Not Provided

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

Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00196911
A 125/00, Grant 01 GI 0201/01 GI 0401
Not Provided
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German Parkinson Study Group (GPS)
Not Provided
Principal Investigator: Guenther Deuschl, Prof. Department of Neurology, Christian-Albrechts University
German Parkinson Study Group (GPS)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP