Parkinson's DiseasePhase 4INVESTNCT02480803
INfusion VErsus STimulation in Parkinson's Disease
A Phase 4 study testing Continuous intrajejunal infusion of levodopa-carbidopa and deep brain stimulation in people with Parkinson's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Continuous intrajejunal infusion of levodopa-carbidopa and deep brain stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Dec 2014to 26 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1100ZZ
About this study
Official title: Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation
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.
Read the detailed description
Rationale: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). As directly comparative studies are lacking, it is unknown whether one of the therapies is more effective. Besides, CLI seems to be more expensive. To determine the optimal treatment in advanced PD, a comparative study of CLI and DBS is warranted.
Hypothesis: We hypothesize that CLI is a more expensive therapy in advanced PD than DBS and that the surplus in costs is not cost-effective with regard to benefits for the patient and caregivers in quality of life, PD symptoms and adverse events.
Objective: To realize a cost-effective treatment strategy in advanced PD. Study design: Prospective, randomized, open label multicentre trial, with two additional patient preference treatment arms ("patient preference randomized trial").
Study population: Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, dyskinesias, painful dystonia, or bradykinesia. A total of 66 patients will be randomized, at least 120 patients will be included in the patient preference arms.
Intervention: Patients will be randomized to DBS or CLI. For DBS treatment, 2 electrodes will be implanted in the brain. The electrodes are connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area. 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.
Main study parameters: There are 8 specified assessment visits: at baseline, and 1 week, 3, 6, 9, 12, 24 and 36 months after start of the study treatment. The primary health economic outcomes are the costs per changed unit on the PDQ-39 (and the costs per changed QALY for the cost-effectiveness and cost-utility analyses, respectively. The EQ-5D will be applied as the utility measure. Change in quality of life (expressed in the between group difference in change from baseline to 12 months on the PDQ-39 summary index score) is the main clinical outcome. Among the secondary outcomes are functional health, complications and adverse effects, use of care and perceptions of patients and neurologists regarding both treatments.
- Conditions
- Parkinson's Disease
- Being tested
- Continuous intrajejunal infusion of levodopa-carbidopa, deep brain stimulation
- Keywords
- Parkinson, Parkinson's Disease, Deep Brain Stimulation, levodopa-carbidopa, Duodopa, continuous intrajejunal infusion
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous intrajejunal infusion of levodopa-carbidopaDrug
Also called Duodopa infusion, Intestinal levodopa-carbidopa infusion
Continuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI)
deep brain stimulationDevice
Also called DBS, DBS-STN
Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)
| Study group | Role | What they receive |
|---|---|---|
| continuous levodopa infusion | Active comparator | continuous intrajejunal infusion of levodopa-carbidopa Receives: Drug: Continuous intrajejunal infusion of levodopa-carbidopa |
| deep brain stimulation | Active comparator | Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness in costs per changed unit on PDQ-39
The costs per changed unit on the PDQ-39.
Measured: 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.
Measured: 12 months
Secondary outcomes (40)
Quality of life (on PDQ-39)
Changes from Baseline on Parkinson's Disease Questionnaire-39 (PDQ-39; score 0-100, higher score is lower quality of life)
Measured: 12, 24 and 36 months
Quality of life (on EQ-5D)
Change from Baseline on EuroQol 5D-3L (EQ-5D; 5 questions, each score 1-3, providing a health state, to be translated with provided Valuation set)
Measured: 12, 24 and 36 months
Motor symptoms
Score changes from Baseline in off and on state on Movement Disorder Society's Unified Parkinson Disease Rating Scale (MDS-UPDRS part 3; 0-132, high score is more motor symptoms)
Measured: 12 and 36 months
Motor symptoms: time in off and on-state
Change from Baseline in time in off-state, on-state without dyskinesias, on-state without troublesome dyskinesias and on-state with troublesome dyskinesias measured with motor symptom diary
Measured: 12, 24 and 36 months
Motor experiences of daily living
Changes from Baseline on MDS-UPDRS part 2 (Movement Disorder Society's Unified Parkinson Disease Rating Scale (MDS-UPDRS part 2; score 0-52, high score is more worse health)
Measured: 12, 24 and 36 months
Dyskinesia
Change from Baseline on clinical Dyskinesia Rating Scale (CDRS; score 0-28, high score is more dyskinesia)
Measured: 12 and 36 months
PD-medication (levodopa-equivalent dose)
Change from Baseline expressed in levodopa-equivalent dose
Measured: 12, 24 and 36 months
Functional health status
Change from Baseline on Amsterdam Linear Disability Score (ALDS, 29 items; 0-100, high score is high level of functional status)
Measured: 12, 24 and 36 months
Non-motor symptoms (Non Motor Symptom Checklist)
Changes from Baseline on Non Motor Symptom Checklist
Measured: 12, 24 and 36 months
Non-motor symptoms (Rotterdam Symptom Checklist
Change from Baseline on Rotterdam Symptom Checklist
Measured: 12, 24 and 36 months
Non-motor symptoms (SCOPA-AUT)
Change from Baseline on SCOPA-AUT (SCales for Outcomes in PArkinson's Autonomic symptoms; score 0-92, higher score is more symptoms)
Measured: 12, 24 and 36 months
Disability
Change from Baseline in Hoehn and Yahr stage (H\&Y stage; 1-5: a higher score is more disease progression)
Measured: 12, 24 and 36 months
Cognitive functioning
Change from Baseline on Parkinson's Disease Cognition Rating Scale (PD-CRS; 0-134, higher score is a result of better cognitive performance)
Measured: 12 and 36 months
Cognitive functioning Mattis
Change from Baseline in Mattis Dementia Rating score (score 0-144, higher score is better cognitive function)
Measured: 12 and 36 months
Neuropsychologic functioning BNT
Change from Baseline in Boston Naming Test (range 0-30, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Letter Fluency
Change from Baseline in Letter Fluency (score 0-100, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning WAIS IV
Change from Baseline in WAIS IV (Wechsler Adult Intelligence Scale IV - subsection similarities; score 0-36, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Reading
Change from Baseline in Dutch Reading Test (0-100, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Word Test
Change from Baseline in 15 word test (0-75, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Memory
Change from Baseline in Rivermead Behavioral memory test (subsection stores; score 0-42, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Trail making
Change from Baseline in Trail making test (score 10-500, higher score is longer time, i.e. worse score)
Measured: 12 and 36 months
Neuropsychologic functioning Color Word
Change from Baseline in Stroop Color Word Test (score 10-1000, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Line Orientation
Change from Baseline in Judgement of line orientation (score 0-30, higher is better)
Measured: 12 and 36 months
Neuropsychologic functioning Clock
Change from Baseline in Clock construction (score 0-14, higher is better)
Measured: 12 and 36 months
Psychiatric disease
Change from Baseline in Mini International Neuropsychiatric Interview
Measured: 12 and 36 months
Apathy
Change from Baseline in Starkstein's Apathy Scale (SAS; score 0-42, high score is more signs of apathy)
Measured: 12, 24 and 36 months
Compulsive Disorders
Change in presence of Compulsive Disorder from Baseline assessed with Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP, utilizing established thresholds)
Measured: 12, 24 and 36 months
Anxiety
Changes from Baseline on Hamilton Anxiety Scale (HAM-A; 0-56, high score is worse outcome)
Measured: 12 and 36 months
Depression
Change from Baseline on Hamilton Depression Rating Scale (HDRS; 0-68, higher score is worse outcome)
Measured: 12 and 36 months
Suicidality
Changes from Baseline on Columbia Suicide Severity Rating Scale (range 0-25, higher score is worse outcome)
Measured: 12 and 36 months
Adverse effects
Number of participants with adverse effects and description of these
Measured: 12, 24 and 36 months
Complications and description of complications
Number of participants with complications and description of these
Measured: 12, 24 and 36 months
Stopping allocated treatment
Number of participants who stopped treatment
Measured: 12, 24 and 36 months
Treatment failure
Number of participants with treatment failure
Measured: 12, 24 and 36 months
Treatment cross-over
Number of participants with treatment cross-over
Measured: 12, 24 and 36 months
Patient satisfaction
Descriptive questionnaire, no scale applied, descriptive statistics
Measured: 12, 24 and 36 months
Patients attitude to treatment
Change from Baseline on Patient Reported Outcome Scale (range 0-128, high score is worse outcome)
Measured: 12, 24 and 36 months
Medical costs
Calculation of the total costs in euro by means of iMCQ (iMTA Medical Consumption Questionnaire)
Measured: 12, 24 and 36 months
Non-medical care costs
Calculation of the total costs in euro by means of iPCQ (iMTA Productivity Cost Questionnaire)
Measured: 12, 24 and 36 months
Caregiver burden
Descriptive questionnaire, no scale applied, descriptive statistics
Measured: 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start19 Dec 2014
- Primary completion7 Dec 2021
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, J.M. Dijk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joke M Dijk, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480803
- Sponsor's protocol ID
- 2014_336
- Other IDs
- 2014-004501-32, 2014
- Acronym
- INVEST
- Status last verified
- Feb 2024
- First submitted
- 4 May 2015
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32005175
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation
- ClinicalTrials.gov ID
- NCT02480803
- Acronym / sponsor ID
- INVEST / 2014_336
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson, Parkinson's Disease, Deep Brain Stimulation, levodopa-carbidopa, Duodopa, continuous intrajejunal infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 19 Dec 2014 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Both Continuous intrajejunal Levodopa Infusion (CLI) and Deep Brain Stimulation (DBS) are accepted therapies for the treatment of advanced Parkinson's disease (PD). As directly comparative studies are lacking, it is unknown whether one of the therapies is more effective. Besides, CLI seems to be more expensive. To determine the optimal treatment in advanced PD, a comparative study of CLI and DBS is warranted.
Hypothesis: We hypothesize that CLI is a more expensive therapy in advanced PD than DBS and that the surplus in costs is not cost-effective with regard to benefits for the patient and caregivers in quality of life, PD symptoms and adverse events.
Objective: To realize a cost-effective treatment strategy in advanced PD. Study design: Prospective, randomized, open label multicentre trial, with two additional patient preference treatment arms ("patient preference randomized trial").
Study population: Patients with PD who, despite optimal pharmacological treatment, have severe response fluctuations, dyskinesias, painful dystonia, or bradykinesia. A total of 66 patients will be randomized, at least 120 patients will be included in the patient preference arms.
Intervention: Patients will be randomized to DBS or CLI. For DBS treatment, 2 electrodes will be implanted in the brain. The electrodes are connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area. 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.
Main study parameters: There are 8 specified assessment visits: at baseline, and 1 week, 3, 6, 9, 12, 24 and 36 months after start of the study treatment. The primary health economic outcomes are the costs per changed unit on the PDQ-39 (and the costs per changed QALY for the cost-effectiveness and cost-utility analyses, respectively. The EQ-5D will be applied as the utility measure. Change in quality of life (expressed in the between group difference in change from baseline to 12 months on the PDQ-39 summary index score) is the main clinical outcome. Among the secondary outcomes are functional health, complications and adverse effects, use of care and perceptions of patients and neurologists regarding both treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| continuous levodopa infusion | Active comparator | Drug: Continuous intrajejunal infusion of levodopa-carbidopacontinuous intrajejunal infusion of levodopa-carbidopa |
| deep brain stimulation | Active comparator | Device: deep brain stimulationBilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous intrajejunal infusion of levodopa-carbidopaAlso: Duodopa infusion, Intestinal levodopa-carbidopa infusionContinuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI) | Drug | continuous levodopa infusion |
| deep brain stimulationAlso: DBS, DBS-STNBilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) | Device | deep brain stimulation |
Primary outcome
Cost effectiveness in costs per changed unit on PDQ-39
Time frame: 12 months
The costs per changed unit on the PDQ-39.
Cost-utility in costs per changed Quality Adjusted Life Year (QALY, years)
Time frame: 12 months
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.
40 secondary outcomes
Quality of life (on PDQ-39)
Time frame: 12, 24 and 36 months
Quality of life (on EQ-5D)
Time frame: 12, 24 and 36 months
Motor symptoms
Time frame: 12 and 36 months
Motor symptoms: time in off and on-state
Time frame: 12, 24 and 36 months
Motor experiences of daily living
Time frame: 12, 24 and 36 months
Dyskinesia
Time frame: 12 and 36 months
PD-medication (levodopa-equivalent dose)
Time frame: 12, 24 and 36 months
Functional health status
Time frame: 12, 24 and 36 months
Non-motor symptoms (Non Motor Symptom Checklist)
Time frame: 12, 24 and 36 months
Non-motor symptoms (Rotterdam Symptom Checklist
Time frame: 12, 24 and 36 months
Non-motor symptoms (SCOPA-AUT)
Time frame: 12, 24 and 36 months
Disability
Time frame: 12, 24 and 36 months
Cognitive functioning
Time frame: 12 and 36 months
Cognitive functioning Mattis
Time frame: 12 and 36 months
Neuropsychologic functioning BNT
Time frame: 12 and 36 months
Neuropsychologic functioning Letter Fluency
Time frame: 12 and 36 months
Neuropsychologic functioning WAIS IV
Time frame: 12 and 36 months
Neuropsychologic functioning Reading
Time frame: 12 and 36 months
Neuropsychologic functioning Word Test
Time frame: 12 and 36 months
Neuropsychologic functioning Memory
Time frame: 12 and 36 months
Neuropsychologic functioning Trail making
Time frame: 12 and 36 months
Neuropsychologic functioning Color Word
Time frame: 12 and 36 months
Neuropsychologic functioning Line Orientation
Time frame: 12 and 36 months
Neuropsychologic functioning Clock
Time frame: 12 and 36 months
Psychiatric disease
Time frame: 12 and 36 months
Apathy
Time frame: 12, 24 and 36 months
Compulsive Disorders
Time frame: 12, 24 and 36 months
Anxiety
Time frame: 12 and 36 months
Depression
Time frame: 12 and 36 months
Suicidality
Time frame: 12 and 36 months
Adverse effects
Time frame: 12, 24 and 36 months
Complications and description of complications
Time frame: 12, 24 and 36 months
Stopping allocated treatment
Time frame: 12, 24 and 36 months
Treatment failure
Time frame: 12, 24 and 36 months
Treatment cross-over
Time frame: 12, 24 and 36 months
Patient satisfaction
Time frame: 12, 24 and 36 months
Patients attitude to treatment
Time frame: 12, 24 and 36 months
Medical costs
Time frame: 12, 24 and 36 months
Non-medical care costs
Time frame: 12, 24 and 36 months
Caregiver burden
Time frame: 12, 24 and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 32005175van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke M Dijk, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous intrajejunal infusion of levodopa-carbidopa and deep brain stimulation in people with Parkinson's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost effectiveness in costs per changed unit on PDQ-39 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.