NCT00807703|Completed
Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"
Select Stim
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Select Stim
Sponsor study identifier
interventional
5
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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 negative side-effects of STN DBS. Our hypothesis is that changes in cognition and behavior during STN DBS are related to stimulation of the non-motor parts of the STN. The primary objective is to avoid cognitive and affective side effects by selective stimulation of the STN motor part. The main objective of this feasibility study is to measure the patients burden and to test the technical feasibility. Intervention: The intervention is an expansion of the classical STN DBS procedure. The targeting using the multichannel registration system by stimulation of the motor cortex and registration of the subthalamic nucleus will be added to the procedure. For this procedure, it is necessary to place a subdural strip under the skull.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 11, 2008
Actual (reported)December 12, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)patients burden
baseline
technical feasibility
baseline
Cognition, and in particular impulsivity and affect.
baseline
Advantage of fMRI above TMS or double contrast MRI in the planning of the OR.
baseline
Select Stim: see summary
Select Stim: see summary
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Maastricht
Maastricht, Limburg, 6202AZ, Netherlands
Mark Janssen, MD
Maastricht University Medical Center
5 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2008
First Posted
December 12, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
December 17, 2009
Record last verified: 2009-12
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Source: ClinicalTrials.gov.
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