INfusion VErsus STimulation in Parkinson's Disease

NCT02480803 | Completed Phase 4 DMC

• 2 other identifiers: 2014_3362014-004501-32
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. The main clinical outcome is quality of life; secondary outcomes are motor symptoms and neurological impairments, among others.

Conditions

Parkinson's Disease

Keywords

Parkinson; Parkinson's Disease; Deep Brain Stimulation; levodopa-carbidopa; Duodopa; continuous intrajejunal infusion

Outcome Measures

Primary Outcomes (2)

• Cost effectiveness in costs per changed unit on PDQ-39

  The costs per changed unit on the PDQ-39.

  12 months

• Cost-utility in costs per changed Quality Adjusted Life Year (QALY, years)

  The costs per QALY. The EuroQol 5D-3L (EQ-5D; 5 questions, each score 1-3, providing a health state, to be translated with provided Valuation set) will be applied as the utility measure.

  12 months

Secondary Outcomes (40)

• Quality of life (on PDQ-39)

  12, 24 and 36 months

• Quality of life (on EQ-5D)

  12, 24 and 36 months

• Motor symptoms

  12 and 36 months

• Motor symptoms: time in off and on-state

  12, 24 and 36 months

• Motor experiences of daily living

  12, 24 and 36 months

Study Arms (2)

continuous levodopa infusion

ACTIVE COMPARATOR

continuous intrajejunal infusion of levodopa-carbidopa

Drug: Continuous intrajejunal infusion of levodopa-carbidopa

deep brain stimulation

ACTIVE COMPARATOR

Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)

Device: deep brain stimulation

Interventions

Continuous intrajejunal infusion of levodopa-carbidopa DRUG

Continuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI)

Also known as: Duodopa infusion, Intestinal levodopa-carbidopa infusion

continuous levodopa infusion

deep brain stimulation DEVICE

Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)

Also known as: DBS, DBS-STN

deep brain stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1100ZZ, Netherlands

Location

Related Publications (1)

• van Poppelen D, Sisodia V, de Haan RJ, Dijkgraaf MGW, Schuurman PR, Geurtsen GJ, Berk AEM, de Bie RMA, Dijk JM. 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. BMC Neurol. 2020 Jan 31;20(1):40. doi: 10.1186/s12883-020-1621-y.

  PMID: 32005175 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Joke M Dijk, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.M. Dijk, MD, PhD, Neurologist, Principal Investigator

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: June 25, 2015
• Study Start: December 19, 2014
• Primary Completion: December 7, 2021
• Study Completion: January 26, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)