Basal Ganglia Disease, Central Nervous System Disease, Movement Disorders, Neurodegenerative Disorders, Parkinson Disease
Conditions
Keywords
Parkinson Disease, Morbus Parkinson, Basal Ganglia, Pallidal Stimulation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREDeep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)
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.
PROCEDUREBest medical treatment
Patients will receive optimized medical treatment according to published evidence based guidelines.
Sponsors
Boston Scientific Corporation
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease according to the UKBB criteria, with the exception that familial forms of otherwise typical parkinsonian syndromes may also be included * motor complications of dopaminergic medication (dyskinesia or motor fluctuations or both) that are at least moderately bothersome to the patient \[on a scale of 5 possible levels: not at all / mildly / moderately / severely / extremely bothersome\] * Presence of at least one of the following absolute
Exclusion criteria
for STN stimulation: * Mattis dementia rating scale \<130 points * postural instability of \>1 in the item of MDS-UPDRS III \[item #12\] on medication * less than 30% improvement of axial score in the acute levodopa challenge test \[axial score =sum of items 3.1, 3.9, 3.10, 3.12, 3.13 of the MDS UPDRS III\] * or presence of at least two of the following relative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 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. | Baseline and 5 months +/- 1 month |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | 5 months +/- 1 months |
Countries
Switzerland
Outcome results
None listed