Treatment in advanced Parkinson*s disease: continuous intrajejunal levodopa infusion versus deep brain stimulation; a feasibility study

Treatment in advanced Parkinson*s disease: continuous intrajejunal levodopa infusion versus deep brain stimulation; a feasibility study - INVEST (INfusion VErsus STimulation) feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39084

Enrollment

Registered

2013-03-22

Start date

2014-03-24

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

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. For DBS treatment,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -idiopathic PD 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 dystonias, or bradykinesia; -a life expectancy of more than two years.

Exclusion criteria

Exclusion criteria: -age below 18 years; -previous PD-neurosurgery (e.g. DBS, pallidotomy, thalamotomy); -previous CLI (through a PEG-tube or Nasal Jejunal tube); -Hoehn and Yahr stage 5 at the best moment during the day; -a Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org); -psychosis; -current depression despite optimal pharmacotherapy; -contraindications for DBS surgery, such as a physical disorder making surgery hazardous; -contraindications for PEG surgery and Duodopa; -pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception; -inability to provide written informed consent; -legally incompetent adults.

Design outcomes

Primary

Measure	Time frame
The main objective is the randomization rate, measured as the percentage of patients that agrees to be randomized to CLI or DBS out of all eligible patients.	—

Secondary

Measure	Time frame
For the cross-sectional study, the secondary outcome measure is a structured interview, qualitatively evaluating the reasons for declining randomization. n the pilot-trial, we will assess the implementation of the research protocol including possible future outcome measures like the PDQ-39, UPDRS, ALDS, and EQ-5D, neuropsychological and psychiatric measures and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)