Deep Brain Stimulation for MOtor symptoms in patients with Parkinson*s disease DEmentia (DBS- MODE)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

• age 18 years and older; • diagnosis of PD according to the clinical
diagnostic criteria of the Movement Disorder Society (MDS); • 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
Parkinson*s disease dementia (PDD) according to the MDS clinical diagnostic
criteria (a.o. this encompasses the development of dementia a*fter established
diagnosis of PD). This will be based on a standardized neuropsychological
examination; i.e. presence of at least 3 abnormal (i.e. < 2 standard
deviations) tests covering at least 2 cognitive domains. If a test cannot be
executed due to severe cognitive difficulties the test is regarded to be
abnormal; • an expected life expectancy of at least two years; • participant
has decision capacity to give informed consent, judgement of which is at the
discretion of an experienced neurologist from the study team; • participant
provides written informed consent; • regular contact with a caregiver, who has
approximately twice a week contact with the participant 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;
• 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);
• 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
<p>Patients will be assessed at baseline, 15 weeks, 30 weeks and 52 weeks after<br /><br>randomization. The primary outcome measure is the change from baseline to 30<br /><br>weeks follow-up of motor symptoms in off-drug phase measured with the Movement<br /><br>Disorder Society - Unified Parkinson*s Disease Rating Scale (MDS-UPDRS) part<br /><br>III.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures include neuropsychological evaluation,<br /><br>psychiatric assessment, additional motor evaluations during on-drug phase,<br /><br>functional health status, falls, usage of medication, (S)AEs, treatment<br /><br>satisfaction, caregiver burden, medical care consumption and recruitment and<br /><br>retention rate.</p><br>

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