Clinical trial NCT00196911: STN-Stimulation Versus Best Medical Treatment in Advanced PD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: German Parkinson Study Group (GPS)
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
measure: Motor Score in the OFF (UPDRS III)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Neurologische Klinik der Charité, Augustenburgerplatz 1
city: Düsseldorf
country: Germany
facility: Neurologische Klinik der Universität, Moorenstr. 5
city: Heidelberg
country: Germany
facility: Neurologische Klinik der Universität, Neuenheimerfeld 400
city: Kiel
country: Germany
facility: Department of Neurology, Schittenhelmstr. 10
city: Köln
country: Germany
facility: Neurologische Klinik der Universität, Gleuelerstr. 50
city: München
country: Germany
facility: Neurologische Klinik der Universität
Study officials:
affiliation: Department of Neurology, Christian-Albrechts University
name: Guenther Deuschl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander 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. doi: 10.1056/NEJMoa060281.
citation: Daniels C, Krack P, Volkmann J, Raethjen J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Is improvement in the quality of life after subthalamic nucleus stimulation in Parkinson's disease predictable? Mov Disord. 2011 Dec;26(14):2516-21. doi: 10.1002/mds.23907. Epub 2011 Aug 25.
citation: Witt K, Daniels C, Krack P, Volkmann J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Negative impact of borderline global cognitive scores on quality of life after subthalamic nucleus stimulation in Parkinson's disease. J Neurol Sci. 2011 Nov 15;310(1-2):261-6. doi: 10.1016/j.jns.2011.06.028. Epub 2011 Jul 5.
citation: Daniels C, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Risk factors for executive dysfunction after subthalamic nucleus stimulation in Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1583-9. doi: 10.1002/mds.23078.
citation: Witt K, Daniels C, Reiff J, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Neuropsychological and psychiatric changes after deep brain stimulation for Parkinson's disease: a randomised, multicentre study. Lancet Neurol. 2008 Jul;7(7):605-14. doi: 10.1016/S1474-4422(08)70114-5. Epub 2008 Jun 4.