Principal Investigators


Prof. P.R. Schuurman

Institution


AMC

Contact information of lead PI


Country


Netherlands

Title of project or programme


Deep brain stimulation surgery under local versus general anesthesia in Parkinson's disease

Source of funding information


Hersenstichting

Total sum awarded (Euro)


€ 257,908

Start date of award


01/03/2016

Total duration of award in years


4

Keywords


Research Abstract


Currently the standard Deep Brain stimulation (DBS) in Parkinson’s (PD) performed under local anesthesia Unfortunately the procedure is very burdensome for patients. Due to advances in modern imaging techniques, it is now possible to visualize the DBS-target directly. Surgery for DBS could therefore be performed under general anesthesia.
The primary objective is to optimize the current DBS-treatment of advanced PD. For the primary objective the following research question will be answered: by performing subthalamic nucleus (STN) DBS under general anesthesia, will there be a significant reduction in cognitive, mood and behavioral adverse effects when compared to STN DBS under local anesthesia?
Secondary objectives are to compare motor symptoms, adverse effects and complications, surgery time, functional health, quality of life, patient satisfaction on the outcome of treatment, and patient evaluation of the burden of therapy.
This study is a single center prospective randomized open label blinded endpoint study. 110 patients with advanced PD with an indication for DBS will be included. The follow-up period will be 6 months.
This study will contribute to reducing the burden of DBS surgery. If DBS surgery under general anesthesia is shown to produce less cognitive, mood and behavioral adverse effects compared to surgery under local anesthesia, this would significantly lower the risk of side effects associated with local anesthesia.
Recruiting countries: The Netherlands

Further information available at:


http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5817

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