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Completed

NCT Number: NCT00196911

STN-Stimulation Versus Best Medical Treatment in Advanced PD

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurologische Klinik der Charité, Augustenburgerplatz 1, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of stimulation electrodes in the STN

Procedure

Primary outcomes

  1. Quality of life

  2. Motor Score in the OFF (UPDRS III)

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Sponsors and collaborators

Lead sponsor

German Parkinson Study Group (GPS)

Other

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Nov 30, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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