Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep Brain Stimulation;
- Conditions
- ParkinsonParkinson's Disease10028037
- Registration Number
- NL-OMON50651
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
- idiopathic Parkinson's Disease 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 dystonia or
bradykinesia;
-a life expectancy of at least two years.
-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;
- dementia or indication for severe cognitive impairment, such as PD-CRS <65;
- psychosis;
- current depression;
- other, severely disabling condition;
- 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 Duodopa;
- pregnancy, breastfeeding, and women of child bearing age not using a reliable
method of contraception;
- No informed consent;
- legally incompetent adults.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary health economic outcomes of the randomized trial are the costs per<br /><br>unit on the PDQ-39 and the costs per QALY for the cost-effectiveness and<br /><br>cost-utility analyses respectively. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary clinical outcomes are quality of life (PDQ-39), PD motor symptoms<br /><br>(UPDRS), dyskinesias (CDRS), 3-day motor symptom diary), adverse effects and<br /><br>complications, treatment failure, non-motor symptoms such as autonomic<br /><br>functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist),<br /><br>PD-medication, disability, functional health status (ALDS), patient and<br /><br>physician preferences, patient satisfaction, caregiver burden,<br /><br>neuropsychological and psychiatric assessment, stopping treatment, starting<br /><br>with the alternative than initially started treatment, and medical and<br /><br>non-medical care costs (iMCQ, iPCQ).</p><br>