NL-OMON39084
Completed
Not Applicable
Treatment in advanced Parkinson*s disease: continuous intrajejunal levodopa infusion versus deep brain stimulation; a feasibility study - INVEST (INfusion VErsus STimulation) feasibility study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 59
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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