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STN-Stimulation Versus Best Medical Treatment in Advanced PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Implantation of stimulation electrodes in the STN
Sponsored by
German Parkinson Study Group (GPS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurologische Klinik der Charité, Augustenburgerplatz 1
  • Neurologische Klinik der Universität, Moorenstr. 5
  • Neurologische Klinik der Universität, Neuenheimerfeld 400
  • Department of Neurology, Schittenhelmstr. 10
  • Neurologische Klinik der Universität, Gleuelerstr. 50
  • Neurologische Klinik der Universität

Outcomes

Primary Outcome Measures

Quality of life
Motor Score in the OFF (UPDRS III)

Secondary Outcome Measures

Full Information

First Posted
September 11, 2005
Last Updated
November 29, 2006
Sponsor
German Parkinson Study Group (GPS)
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1. Study Identification

Unique Protocol Identification Number
NCT00196911
Brief Title
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

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
German Parkinson Study Group (GPS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Implantation of stimulation electrodes in the STN
Primary Outcome Measure Information:
Title
Quality of life
Title
Motor Score in the OFF (UPDRS III)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenther Deuschl, Prof.
Organizational Affiliation
Department of Neurology, Christian-Albrechts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurologische Klinik der Charité, Augustenburgerplatz 1
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Neurologische Klinik der Universität, Moorenstr. 5
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Neurologische Klinik der Universität, Neuenheimerfeld 400
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Department of Neurology, Schittenhelmstr. 10
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Neurologische Klinik der Universität, Gleuelerstr. 50
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Neurologische Klinik der Universität
City
München
ZIP/Postal Code
81337
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16943402
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. Erratum In: N Engl J Med. 2006 Sep 21;355(12):1289.
Results Reference
result
PubMed Identifier
22170276
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.
Results Reference
derived
PubMed Identifier
21733529
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.
Results Reference
derived
PubMed Identifier
20589868
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.
Results Reference
derived
PubMed Identifier
18538636
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.
Results Reference
derived
Links:
URL
http://www.kompetenznetz-parkinson.de/
Description
German Research Collaboration, funded by the German Ministery of Research
URL
http://www.kks-mr.de
Description
Homepage Coordination Center for Clinical Studies to STN Study, Language: German

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STN-Stimulation Versus Best Medical Treatment in Advanced PD

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