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NCT00196911 Clinical Trial

STN-Stimulation Versus Best Medical Treatment in Advanced PD

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00196911
Other study ID # A 125/00
Secondary ID Grant 01 GI 0201
Status Completed
Phase Phase 3
First received September 11, 2005
Last updated November 29, 2006
Start date January 2001
Est. completion date January 2005

Study information
Verified date September 2005
Source German Parkinson Study Group (GPS)
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Implantation of stimulation electrodes in the STN

Locations
Country Name City State
Germany Neurologische Klinik der Charité, Augustenburgerplatz 1 Berlin
Germany Neurologische Klinik der Universität, Moorenstr. 5 Düsseldorf
Germany Neurologische Klinik der Universität, Neuenheimerfeld 400 Heidelberg
Germany Department of Neurology, Schittenhelmstr. 10 Kiel
Germany Neurologische Klinik der Universität, Gleuelerstr. 50 Köln
Germany Neurologische Klinik der Universität München

Sponsors (1)
Lead Sponsor Collaborator
German Parkinson Study Group (GPS)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schäfer H, Bötzel K, Daniels C, Deutschländer A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life
Primary Motor Score in the OFF (UPDRS III)
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