STN-Stimulation Versus Best Medical Treatment in Advanced PD

November 29, 2006 updated by: German Parkinson Study Group (GPS)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Neurologische Klinik der Charité, Augustenburgerplatz 1
      • Düsseldorf, Germany, 40225
        • Neurologische Klinik der Universität, Moorenstr. 5
      • Heidelberg, Germany, 69120
        • Neurologische Klinik der Universität, Neuenheimerfeld 400
      • Kiel, Germany, 24105
        • Department of Neurology, Schittenhelmstr. 10
      • Köln, Germany, 50931
        • Neurologische Klinik der Universität, Gleuelerstr. 50
      • München, Germany, 81337
        • Neurologische Klinik der Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Parkinson Study Group (GPS)

Investigators

  • Principal Investigator: Guenther Deuschl, Prof., Department of Neurology, Christian-Albrechts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 17, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 125/00
  • Grant 01 GI 0201/01 GI 0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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