Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study" (Select Stim)
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|ClinicalTrials.gov Identifier: NCT00807703|
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : December 17, 2009
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: Select Stim||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Select Stim: Selective Stimulation of the Subthalamic Nucleus in Parkinson's Disease. "A Feasibility Study"|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Select Stim: see summary
Procedure: Select Stim
Select Stim: see summary
- patients burden [ Time Frame: baseline ]
- technical feasibility [ Time Frame: baseline ]
- Cognition, and in particular impulsivity and affect. [ Time Frame: baseline ]
- Advantage of fMRI above TMS or double contrast MRI in the planning of the OR. [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807703
|University Hospital Maastricht|
|Maastricht, Limburg, Netherlands, 6202AZ|
|Principal Investigator:||Mark Janssen, MD||Maastricht University Medical Center|