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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment. Best medical treatment is applied in combination with GPi-DBS.
Patients will receive optimized medical treatment according to published evidence based guidelines.
Inselspital University Hospital Bern
Bern, Switzerland
Difference of change of the score of the Parkinson's disease questionnaire 39 (PDQ-39-SI) from baseline to follow-up between the two treatment groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" without troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change of the score of the MDS-UPDRS part III (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part III) from baseline to follow up between the two trial groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change of the score of the MDS-UPDRS part IV (Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale, part IV) (MDS-UPDRS) from baseline to follow up between the two trial groups.
Time frame: Baseline and 5 months +/- 1 month
Difference of change in number of hours per day spent in motor "on" with troublesome dyskinesia from baseline to follow-up between the two treatment groups.
Time frame: 5 months +/- 1 months
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