Deep brain stimulation for motor symptoms in patients with Parkinson’s disease dementia

Recruiting

Conditions: Parkinson's disease

Registration Number: NL-OMON24650

Lead Sponsor: one

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 44

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:
omotor response fluctuations;
odyskinesia;
opainful dystonia;
olevodopa-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

•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:
othat causes cognitive impairment that may improve with specific treatment; OR
othat 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.