The INVEST study Treatment in advanced Parkinson’s disease: continuous intrajejunal levodopa INfusion VErsus deep brain STimulation.
Phase 3
Completed
- Conditions
- <p>advanced Parkinson's disease, gevorderde ziekte van Parkinson</p>10028037
- Registration Number
- NL-OMON21505
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
- 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;
Exclusion Criteria
- Age below 18 years
- Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The costs per unit on the PDQ-39 and the costs per QALY for the cost-effectiveness and cost-utility analyses respectively. The EQ-5D will be applied as the utility measure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary clinical outcomes are quality of life (PDQ-39 at baseline, 9 and 12 months), PD motor symptoms (MDS-UPDRS-score at baseline and 12 months), dyskinesias (CDRS at baseline and 12 months), 3-day motor symptom diary (at baseline and 12 months), non-motor symptoms such as autonomic functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist at baseline and 12 months), adverse effects and complications (at every visit), treatment failure (at every visit), stopping treatment, starting with the alternative than initially started treatment, PD-medication (at every visit), disability (Hoehn and Yahr stage at baseline and 12 months), functional health status (ALDS at baseline and 12 months), patient and physician preferences, patient satisfaction, caregiver burden, neuropsychological and psychiatric assessment at baseline and 12 months, and medical and non-medical care costs (iMCQ and iPCQ at every visit).</p><br>