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.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
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.
- Procedure: Implantation of stimulation electrodes in the STN
Clinical Trial Outcome Measures
- Quality of life
- Motor Score in the OFF (UPDRS III)
Participating in This Clinical Trial
advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2
age>75 years depression psychosis surgical contraindications
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- German Parkinson Study Group (GPS)
- Overall Official(s)
- Guenther Deuschl, Prof., Principal Investigator, Department of Neurology, Christian-Albrechts University
Citations Reporting on Results
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, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. Erratum in: N Engl J Med. 2006 Sep 21;355(12):1289.
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