Parkinson's disease
Conditions
Interventions
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: • age 18 years and older; • diagnosis of PD according to the clinical diagnostic criteria of the Movement Disorder Society (MDS) (22) – see Appendix 13.3; • despite optimal pharmacological treatment, at least one of the following symptoms, that are severe enough to impair functioning in daily life independent of dementia: o motor response fluctuations; o dyskinesia; o painful dystonia; o levodopa-responsive bradykinesia; • diagnosis of probable or possible PDD according to the MDS clinical diagnostic criteria (6) – see Appendix 13.4 (amongst others this encompasses the development of dementia áfter established diagnosis of PD). This will be based on a standardized neuropsychological examination; i.e. presence of at least 2 abnormal cognitive domains, each consisting of 2 abnormal (i.e., = 2 standard deviations) tests, so at least 4 abnormal tests in total. If a test cannot be executed due to severe cognitive difficulties the test is regarded to be abnormal; • a life expectancy of at least two years; • subject has decision capacity to give informed consent, judgement of which is at the discretion of an experienced neurologist from the study team (see 7.3); • subject provides written informed consent; • regular contact with a caregiver, who has at least approximately twice a week contact with the subject and also provides written informed consent for their own participation.
Exclusion criteria
Exclusion criteria: • any neurodegenerative disorder other than PD; • previous neurosurgery for PD (e.g., DBS, pallidotomy, thalamotomy). Nota bene: intrajejunal levodopa infusion or subcutaneous apomorphine infusion are not considered an exclusion criterion; • contraindications for DBS surgery, such as a physical disorder making surgery hazardous; • Hoehn and Yahr stage 4 or 5 at the best moment during the day (23); • co-existence of another abnormality or disorder: o that causes cognitive impairment that may improve with specific treatment; OR o that besides PDD is judged to contribute significantly to the cognitive impairment by the treating physician; • current major depressive episode according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (24) – see Appendix 13.5; • current psychosis (treatment with antipsychotics is allowed); • other severely disabling condition; • immobility during the greater part of the day not related to off-drug phase (e.g., due to apathy); • pregnancy, breastfeeding, and women of childbearing age not using a reliable method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to 30 weeks on the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part III score (i.e., motor signs) in a standardized off-drug phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary outcome measures consist of scales assessing cognitive aspects of daily living, neuropsychiatric symptoms and impulsive compulsive disorders. Additional secondary outcome measures encompass motor signs during on-drug phase, dyskinesias, motor fluctuations, cognitive performance, functional health status, incidence of falls, use of PD medication, (S)AEs, treatment satisfaction, caregiver burden, recruitment and retention rate, and medical care use. | — |
Contacts
Public ContactBart Swinnen
Amsterdam UMC, location AMC
Outcome results
None listed