STN-Stimulation Versus Best Medical Treatment in Advanced PD

Phase 3

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00196911
• Lead Sponsor: German Parkinson Study Group (GPS)

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.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2005-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-17
• Study First Posted: 2005-09-20
• Last Update Submitted: 2006-11-29
• Last Update Posted: 2006-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (6)

Neurologische Klinik der Charité, Augustenburgerplatz 1; 🇩🇪 Berlin, Germany

Neurologische Klinik der Universität, Moorenstr. 5; 🇩🇪 Düsseldorf, Germany

Department of Neurology, Schittenhelmstr. 10; 🇩🇪 Kiel, Germany

Neurologische Klinik der Universität, Neuenheimerfeld 400; 🇩🇪 Heidelberg, Germany

Neurologische Klinik der Universität, Gleuelerstr. 50; 🇩🇪 Köln, Germany

Neurologische Klinik der Universität; 🇩🇪 München, Germany