None listed
Conditions
Interventions
A neurosurgical procedure using stereotactic techniques will be employed for
implantation of two electrodes with the functional contact at both subthalamic
nuclei or both globus pallidus. The electr
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria are idiopathic Parkinson's disease and * despite optimal pharmacological treatment * at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: age below 18 years, previous functional stereotactic neurosurgery, Hoehn and Yahr stage 5 at the best moment during the day, a MATTIS dementia rating scale score of 120 or less, current psychosis or depression, and contraindications for stereotactic neurosurgery such as a physical disorder making surgery hazardous (severe hypertension, blood coagulation disorder, severe dysphagia, or dysarthria).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline and outcome measurements at 12 months will be done in standardized off and on phases. The primary outcome measures are the Neuropsychiatric Inventory (cognition, mood, and behavior) and the off-on phase weighted AMC Linear Disability Scale (functional improvement). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome consists of symptom scales, activities of daily living scales, a quality of life questionnaire, adverse effects, and medication use. Additionally, patients will undergo extensive neuropsychological assessment. | — |
Countries
Netherlands
Outcome results
None listed