Treatment in advanced Parkinson*s disease: continuous intrajejunal levodopa infusion versus deep brain stimulation; a feasibility study

Completed

Conditions: Parkinson's Disease
Parkinson
10028037

Registration Number: NL-OMON39084

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 59

Inclusion Criteria

-idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;
-despite optimal pharmacological treatment at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia;
-a life expectancy of more than two years.

Exclusion Criteria

-age below 18 years;
-previous PD-neurosurgery (e.g. DBS, pallidotomy, thalamotomy);
-previous CLI (through a PEG-tube or Nasal Jejunal tube);
-Hoehn and Yahr stage 5 at the best moment during the day;
-a Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org);
-psychosis;
-current depression despite optimal pharmacotherapy;
-contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
-contraindications for PEG surgery and Duodopa;
-pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
-inability to provide written informed consent;
-legally incompetent adults.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective is the randomization rate, measured as the percentage of<br /><br>patients that agrees to be randomized to CLI or DBS out of all eligible<br /><br>patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For the cross-sectional study, the secondary outcome measure is a structured<br /><br>interview, qualitatively evaluating the reasons for declining randomization.<br /><br><br /><br>n the pilot-trial, we will assess the implementation of the research protocol<br /><br>including possible future outcome measures like the PDQ-39, UPDRS, ALDS, and<br /><br>EQ-5D, neuropsychological and psychiatric measures and costs.</p><br>