The INVEST study Treatment in advanced Parkinson’s disease: continuous intrajejunal levodopa INfusion VErsus deep brain STimulation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21505

Enrollment

Registered

2014-11-03

Start date

2014-12-19

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

advanced Parkinson's disease, gevorderde ziekte van Parkinson

Interventions

Continuous Intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS).

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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; - A Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org); - 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary clinical outcomes are quality of life (PDQ-39 at baseline, 9 and 12 months), PD motor symptoms (MDS-UPDRS-score at baseline and 12 months), dyskinesias (CDRS at baseline and 12 months), 3-day motor symptom diary (at baseline and 12 months), non-motor symptoms such as autonomic functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist at baseline and 12 months), adverse effects and complications (at every visit), treatment failure (at every visit), stopping treatment, starting with the alternative than initially started treatment, PD-medication (at every visit), disability (Hoehn and Yahr stage at baseline and 12 months), functional health status (ALDS at baseline and 12 months), patient and physician preferences, patient satisfaction, caregiver burden, neuropsychological and psychiatric assessment at baseline and 12 months, and medical and non-medical care costs (iMCQ and iPCQ at every visit).	—

Measure

Time frame

Secondary clinical outcomes are quality of life (PDQ-39 at baseline, 9 and 12 months), PD motor symptoms (MDS-UPDRS-score at baseline and 12 months), dyskinesias (CDRS at baseline and 12 months), 3-day motor symptom diary (at baseline and 12 months), non-motor symptoms such as autonomic functions and sleep (Non Motor Symptom Checklist, Rotterdam Symptom Checklist at baseline and 12 months), adverse effects and complications (at every visit), treatment failure (at every visit), stopping treatment, starting with the alternative than initially started treatment, PD-medication (at every visit), disability (Hoehn and Yahr stage at baseline and 12 months), functional health status (ALDS at baseline and 12 months), patient and physician preferences, patient satisfaction, caregiver burden, neuropsychological and psychiatric assessment at baseline and 12 months, and medical and non-medical care costs (iMCQ and iPCQ at every visit).

—

Contacts

Public ContactJ.M. Dijk

Academisch Medisch Centrum Afdeling Neurologie Postbus 22660

j.m.dijk@amc.uva.nl020-5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)