STN-Stimulation Versus Best Medical Treatment in Advanced PD - Full Text View

Sponsor:	German Parkinson Study Group (GPS)
Information provided by:	German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:	NCT00196911

Purpose

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196911

Locations

Germany
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)

Investigators

Principal Investigator:

Guenther Deuschl, Prof.

Department of Neurology, Christian-Albrechts University

More Information

Additional Information:

German Research Collaboration, funded by the German Ministery of Research This link exits the ClinicalTrials.gov site

Homepage Coordination Center for Clinical Studies to STN Study, Language: German This link exits the ClinicalTrials.gov site

Publications:

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. Erratum in: N Engl J Med. 2006 Sep 21;355(12):1289.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daniels C, Krack P, Volkmann J, Raethjen J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Bötzel 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. Epub 2011 Aug 25.

Witt K, Daniels C, Krack P, Volkmann J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Bötzel 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. Epub 2011 Jul 5.

Daniels C, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Bötzel 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.

Witt K, Daniels C, Reiff J, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Bötzel 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. Epub 2008 Jun 4.

ClinicalTrials.gov 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
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 09, 2012