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Trial record 2 of 2 for:    deuschl deep brain stimulation

STN-Stimulation Versus Best Medical Treatment in Advanced PD

This study has been completed.
Sponsor:
Information provided by:
German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:
NCT00196911
First received: September 11, 2005
Last updated: November 29, 2006
Last verified: September 2005
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014