Status:
COMPLETED
Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
In the advanced stages of Parkinson Disease deep brain stimulation of the subthalamic nucleus (STN DBS) is the next therapeutic option. Despite the beneficial motor effects there are important negativ...
Detailed Description
Parkinson disease (PD) is a common neurodegenerative disorder, characterized by motor symptoms. Patients are initially treated successfully with drugs (e.g. levodopa), unfortunately use is limited due...
Eligibility Criteria
Inclusion
- Patients between 40-75 years old
- clinical findings consistent with idiopathic PD
- suffer from severe response fluctuations and/or dyskinesias,
- despite optimal drug treatment
- initially a good response on levodopa.
Exclusion
- psychiatric co-morbidities and cognitive decline, e.g. dementia and psychosis, are excluded from this study.
- The mini mental state exam (MMSE) score is not allowed to be \<24.
- significant cerebral atrophy,
- causative factors of PD,
- multiple white matter lesions or
- focal brain anomalies
- Hoehn and Yahr stage of 5 at the best moment of the day.
- general contra-indications for surgery are considered as exclusion criteria, e.g. coagulopathies.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00807703
Start Date
September 1 2008
End Date
December 1 2009
Last Update
December 17 2009
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6202AZ