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STN-Stimulation Versus Best Medical Treatment in Advanced PD

NCT ID: NCT00196911

Last Updated: 2006-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Implantation of stimulation electrodes in the STN

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Parkinson Study Group (GPS)

OTHER

Sponsor Role lead

Principal Investigators

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Guenther Deuschl, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Christian-Albrechts University

Locations

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Neurologische Klinik der Charité, Augustenburgerplatz 1

Berlin, , Germany

Site Status

Neurologische Klinik der Universität, Gleuelerstr. 50

Cologne, , Germany

Site Status

Neurologische Klinik der Universität, Moorenstr. 5

Düsseldorf, , Germany

Site Status

Neurologische Klinik der Universität, Neuenheimerfeld 400

Heidelberg, , Germany

Site Status

Department of Neurology, Schittenhelmstr. 10

Kiel, , Germany

Site Status

Neurologische Klinik der Universität

München, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 16943402 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22170276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21733529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20589868 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18538636 (View on PubMed)

Related Links

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http://www.kompetenznetz-parkinson.de/

German Research Collaboration, funded by the German Ministery of Research

http://www.kks-mr.de

Homepage Coordination Center for Clinical Studies to STN Study, Language: German

Other Identifiers

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Grant 01 GI 0201/01 GI 0401

Identifier Type: -

Identifier Source: secondary_id

A 125/00

Identifier Type: -

Identifier Source: org_study_id