INfusion VErsus STimulation in Parkinson's Disease

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    66
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 22 January 2021
levodopa
dyskinesia
carbidopa
brain stimulation
tremor
bradykinesia
muscle rigidity
resting tremor
duodopa

Summary

Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). To date, no comparative studies have been executed. The INVEST study is an open label randomised controlled trial with cost-effectiveness as primary outcome. Secondary outcomes will be quality of life, neurological impairments, among others.

Description

Rationale: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). As directly comparative studies are lacking, it is unknown whether one of the therapies is more effective. Besides, CLI seems to be more expensive. To determine the optimal treatment in advanced PD, a comparative study of CLI and DBS is warranted.

Hypothesis: We hypothesize that CLI is a more expensive therapy in advanced PD than DBS and that the surplus in costs is not cost-effective with regard to benefits for the patient and caregivers in quality of life, PD symptoms and adverse events.

Objective: To realize a cost-effective treatment strategy in advanced PD. Study design: Prospective, randomized, open label multicentre trial, with two additional patient preference treatment arms ("patient preference randomized trial").

Study population: 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 least 120 patients will be included in the patient preference arms.

Intervention: Patients will be randomized to DBS or CLI. For DBS treatment, 2 electrodes will be implanted in the brain. The electrodes are connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area. For CLI treatment, a tube will be placed in the jejunum via a percutaneous endoscopic gastrostomy (PEG). This tube is connected to an external pump that delivers the levodopa-gel.

Main study parameters: There are 8 specified assessment visits: at baseline, and 1 week, 3, 6, 9, 12, 24 and 36 months after start of the study treatment. The primary health economic outcomes are 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. Among the secondary outcomes are quality of life, functional health, complications and adverse effects, use of care and perceptions of patients and neurologists regarding both treatments.

Details
Condition Parkinson's disease, parkinson's, parkinson disease
Treatment Deep brain stimulation, Continuous intrajejunal infusion of levodopa-carbidopa
Clinical Study IdentifierNCT02480803
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
A life expectancy of at least two years

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
Other severely disabling disease
Dementia or signs of severe cognitive impairment
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 Duodopa
Pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception
No informed consent
Legally incompetent adults
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