Protocol of a randomized open label multicentre trial comparing continuous intrajejunal levodopa infusion with deep brain stimulation in Parkinson's disease - the INfusion VErsus STimulation (INVEST) study

Autor: Gert J. Geurtsen, A. E. M. Berk, Joke M. Dijk, R.J. de Haan, D. van Poppelen, R. M. A. de Bie, P.R. Schuurman, V. Sisodia, Marcel G. W. Dijkgraaf
Přispěvatelé: Graduate School, Neurology, Amsterdam Neuroscience - Neurodegeneration, APH - Methodology, Clinical Research Unit, Epidemiology and Data Science, Neurosurgery, Medical Psychology, AMS - Restoration & Development, Amsterdam Movement Sciences, APH - Mental Health, APH - Aging & Later Life
Rok vydání: 2019
Předmět:
Male
medicine.medical_specialty
Levodopa
Parkinson's disease
Deep brain stimulation
medicine.medical_treatment
Deep Brain Stimulation
lcsh:RC346-429
law.invention
Antiparkinson Agents
03 medical and health sciences
Study Protocol
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Internal medicine
Medicine
Humans
030212 general & internal medicine
Patient preference trial
Continuous intrajejunal levodopa infusion
lcsh:Neurology. Diseases of the nervous system
Aged
Dystonia
business.industry
Parkinson Disease
Cost-effectiveness analyses
General Medicine
Middle Aged
medicine.disease
nervous system diseases
Research Design
Costs and Cost Analysis
Parkinson’s disease
Observational study
Female
Neurology (clinical)
Neurosurgery
business
030217 neurology & neurosurgery
medicine.drug
Zdroj: BMC Neurology
BMC Neurology, Vol 20, Iss 1, Pp 1-9 (2020)
BMC neurology, 20(1):40. BioMed Central
ISSN: 1471-2377
Popis: Background Both Deep Brain Stimulation (DBS) and Continuous intrajejunal Levodopa Infusion (CLI) are effective therapies for the treatment of Parkinson’s disease (PD). To our knowledge, no direct head-to-head comparison of DBS and CLI has been performed, whilst the costs probably differ significantly. In the INfusion VErsus STimulation (INVEST) study, costs and effectiveness of DBS and CLI are compared in a randomized controlled trial (RCT) in patients with PD, to study whether higher costs of one of the therapies are justified by superiority of that treatment. Methods A prospective open label multicentre RCT is being performed, with ancillary patient preference observational arms. Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, bradykinesia, dyskinesias, or painful dystonia are eligible for inclusion. A total of 66 patients will be randomized. There is no minimal inclusion in the patient preference arms. The primary health economic outcomes are costs per unit on the Parkinson’s Disease Questionnaire-39 (PDQ-39) and costs per unit Quality-Adjusted Life Year (QALY) at 12 months. The main clinical outcome is patient-reported quality of life measured with the PDQ-39 at 12 months. Patients will additionally be followed during 36 months after initiation of the study treatment. Discussion The INVEST trial directly compares the costs and effectiveness of the advanced therapies DBS and CLI. Trial registration Dutch Trial Register identifier 4753, registered November 3rd, 2014; EudraCT number 2014–001501-32, Clinicaltrials.gov: NCT02480803.
Databáze: OpenAIRE
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