EUCTR2014-004501-32-NLActive, not recruitingPhase 1
Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation)
Academic Medical Center0 sites66 target enrollmentStarted: December 3, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 66
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. idiopathic PD with bradykinesia and at least two of the following
- •signs; resting tremor, rigidity, and asymmetry;
- •2. despite optimal pharmacological treatment at least one of the
- •following symptoms: severe response fluctuations, dyskinesias, painful
- •dystonia, or bradykinesia;
- •3. a life expectancy of more than two years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
Exclusion Criteria
- •age below 18 years
- •- previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
- •- previous CLI (through a PEG-tube or Nasal Jejuna| 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;
- •- contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
- •- contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for
- •- pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
- •- No informed consent;
- •- legally incompetent adult
Investigators
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