Dr. J.M. Dijk
Academisch Medisch Centrum
The INVEST study (Infusion VErsus STimulation), a cost-effectiveness analysis of the treatment of advanced Parkinsons disease comparing Continuous Levodopa Infusion to the traditional standard treatment Deep Brain Stimulation
Parkinson's disease & PD-related disorders
OBJECTIVE(S)/RESEARCH QUESTION(S) To realize a cost-effective treatment strategy in advanced Parkinsons disease (PD). Do additional costs of the frequently used Continuous Levodopa Infusion (CLI) lead to a sufficient increase in quality of life, compared to traditional standard treatment with Deep Brain Stimulation (DBS)?
HYPOTHESIS CLI is no cost-effective therapy.
STUDY DESIGN Prospective, randomized, open label multicenter trial, with two additional patient preference treatment arms (patient preference randomized trial).
STUDY POPULATION(S)/DATASETS Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, dyskinesias, painful dystonia, or bradykinesia. A total of 66 patients will be randomized, at least120 patients will be included in the patient preference arms.
INTERVENTION For CLI treatment, a tube will be placed in the jejunum via a percutaneous endoscopic gastrostomy (PEG). The tube is connected to an external pump that delivers the Levodopa-gel.