Skip to content

STN-Stimulation Versus Best Medical Treatment in Advanced PD

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00196911
Enrollment
156
Registered
2005-09-20
Start date
2001-01-31
Completion date
2005-01-31
Last updated
2006-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

PROCEDUREImplantation of stimulation electrodes in the STN

Sponsors

German Parkinson Study Group (GPS)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Quality of life
Motor Score in the OFF (UPDRS III)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026