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

one0 个研究点目标入组 44 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•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.

•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.

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