INfusion VErsus STimulation in Parkinson's Disease

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

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;