Parkinson Disease Clinical Trial
Official title:
A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation
Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.
The indication and excellent therapeutic effects of STN stimulation have been sufficiently
proven in advanced PD, and the contraindications for this treatment are rather well
established. Also, the observation that patients fulfilling the "STN-profile" but who had
been operated for pallidal DBS and lost part of the treatment's benefit over time, improved
when stimulated later in the STN (instead of the GPi) shows that patients qualifying for
STN-DBS do not have as good a result with GPi-DBS.
GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially
postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly
considered to be exclusion criteria for STN stimulation but not for GPi stimulation.
Therefore, the investigators propose a prospective randomized controlled trial of GPi
stimulation in patients with PD and motor complications who have relative or absolute
contraindications for STN stimulation.
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