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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2024
Main ID:	NCT02480803
Date of registration:	04/05/2015
Prospective Registration:	No
Primary sponsor:	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Public title:	INfusion VErsus STimulation in Parkinson's Disease INVEST
Scientific title:	Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation
Date of first enrolment:	December 19, 2014
Target sample size:	51
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT02480803
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Netherlands

Contacts

Name:	Joke M Dijk, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Key inclusion & exclusion 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;

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Continuous intrajejunal infusion of levodopa-carbidopa

Device: deep brain stimulation

Primary Outcome(s)

Cost-utility in costs per changed Quality Adjusted Life Year (QALY, years) [Time Frame: 12 months]

Cost effectiveness in costs per changed unit on PDQ-39 [Time Frame: 12 months]

Secondary Outcome(s)

Caregiver burden [Time Frame: 12, 24 and 36 months]

Complications and description of complications [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning Memory [Time Frame: 12 and 36 months]

Cognitive functioning Mattis [Time Frame: 12 and 36 months]

Neuropsychologic functioning WAIS IV [Time Frame: 12 and 36 months]

Depression [Time Frame: 12 and 36 months]

Neuropsychologic functioning Letter Fluency [Time Frame: 12 and 36 months]

Non-motor symptoms (Rotterdam Symptom Checklist [Time Frame: 12, 24 and 36 months]

Patients attitude to treatment [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning Line Orientation [Time Frame: 12 and 36 months]

Neuropsychologic functioning Trail making [Time Frame: 12 and 36 months]

Psychiatric disease [Time Frame: 12 and 36 months]

Treatment failure [Time Frame: 12, 24 and 36 months]

Apathy [Time Frame: 12, 24 and 36 months]

Dyskinesia [Time Frame: 12 and 36 months]

Adverse effects [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning BNT [Time Frame: 12 and 36 months]

Medical costs [Time Frame: 12, 24 and 36 months]

Motor symptoms [Time Frame: 12 and 36 months]

Stopping allocated treatment [Time Frame: 12, 24 and 36 months]

Treatment cross-over [Time Frame: 12, 24 and 36 months]

Motor symptoms: time in off and on-state [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning Clock [Time Frame: 12 and 36 months]

Compulsive Disorders [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning Reading [Time Frame: 12 and 36 months]

Neuropsychologic functioning Color Word [Time Frame: 12 and 36 months]

Non-medical care costs [Time Frame: 12, 24 and 36 months]

Neuropsychologic functioning Word Test [Time Frame: 12 and 36 months]

Non-motor symptoms (SCOPA-AUT) [Time Frame: 12, 24 and 36 months]

Disability [Time Frame: 12, 24 and 36 months]

Functional health status [Time Frame: 12, 24 and 36 months]

Motor experiences of daily living [Time Frame: 12, 24 and 36 months]

Non-motor symptoms (Non Motor Symptom Checklist) [Time Frame: 12, 24 and 36 months]

Patient satisfaction [Time Frame: 12, 24 and 36 months]

PD-medication (levodopa-equivalent dose) [Time Frame: 12, 24 and 36 months]

Quality of life (on EQ-5D) [Time Frame: 12, 24 and 36 months]

Quality of life (on PDQ-39) [Time Frame: 12, 24 and 36 months]

Anxiety [Time Frame: 12 and 36 months]

Cognitive functioning [Time Frame: 12 and 36 months]

Suicidality [Time Frame: 12 and 36 months]

Secondary ID(s)

2014_336

2014-004501-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ZonMw: The Netherlands Organisation for Health Research and Development

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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