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Idiopathic Parkinson's DiseasePhase 2VANTAGENCT01221948

Vercise Implantable Stimulator for Treating Parkinson's Disease

A Phase 2 study testing Deep Brain Stimulation in people with Idiopathic Parkinson's Disease, run by Boston Scientific Corporation at 7 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic… Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
Deep Brain Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
7 sitesin 6 countries
Study dates
Oct 2010to 1 Jun 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia.
  • Duration of bilateral idiopathic PD of more than five years.
  • Stable medications
  • UPDRS subset III score of ≥30 without medication.
  • Lack of dementia or depression.
  • Must improve with antiparkinsonian medication, but have some motor complications that are not well controlled by medications.
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  • Must be an appropriate candidate for the surgical procedures required for bilateral STN DBS.
  • Is willing and able to comply with all visits and study related procedures
  • Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Who cannot join

  • Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
  • Any finding in neuropsychological screening assessments that would contraindicate DBS surgery, including dementia.
  • Any significant psychiatric problems, including unrelated clinically significant depression.
  • Any current drug or alcohol abuse.
  • Any history of recurrent or unprovoked seizures.
  • Frequent falls while receiving good medication therapy without dyskinesias (on-state).
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  • Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  • Any other active implanted device.
  • Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
  • A history of neurostimulation intolerance in any area of the body.
  • A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
  • Currently on any anticoagulant medications that can not be discontinued during perioperative period.
  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
  • Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  • A female that is breastfeeding or of child bearing potential with a positive urine pregnancy test or not using adequate contraception.

Trial locations and contacts

7 sites in 6 countries.

7 sites in 6 countries

United Kingdom2 sites

  • Frenchay Hospital

    Bristol

  • Southmead Hospital Bristol

    Bristol

Other trials in United Kingdom

Austria1 site

  • Allgemeines Krankenhaus AKH

    Vienna

Other trials in Austria

France1 site

  • CHU de Rennes-Pontchaillou

    Rennes

Other trials in France

Germany1 site

  • Uniklinik Köln

    Cologne

Other trials in Germany

Italy1 site

  • IRCCS Istituto Ortopedico Galeazzi

    Milan

Other trials in Italy

Spain1 site

  • Hospital Central de Asturias

    Oviedo

Other trials in Spain

About this study

Official title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

Read the detailed description

This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effectiveness, safety, and health economic data for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

Being tested
Deep Brain Stimulation
Keywords
Deep Brain Stimulation, Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain StimulationDevice

    Rechargeable Deep Brain Stimulation System

Study groups in NCT01221948
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalRechargeable Deep Brain Stimulation System
Receives: Device: Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).

    Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.

    Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.

    Measured: 26 weeks post first lead implantation

Secondary outcomes (7)

  1. Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.

    Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.

    Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.

    Measured: 12 and 52 weeks post first lead implantation

  2. Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.

    Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items.

    Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52.

    Measured: 12, 26 and 52 weeks post first lead implantation

  3. Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation

    All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post implantation

    Measured: 12, 26 and 52 weeks post first lead implantation

  4. Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.

    Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record "on", "on with troublesome dyskinesia", "off", and "asleep" times for three consecutive days.

    Measured: 12, 26 and 52 weeks post first lead implantation

  5. Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.

    The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:

    • mobility
    • activities of daily living
    • emotional well-being
    • stigma
    • social support
    • cognitions
    • communication
    • bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure.

    Measured: 12, 26 and 52 weeks post first lead implantation

  6. Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on

    The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients' ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).

    Measured: 12, 26 and 52 weeks post first lead implantation

  7. Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.

    Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: ("very much improved" to "marked worsening"). This assessment was completed by the neurologist.

    Measured: 52 weeks post first lead implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2013
  4. Study completion1 Jun 2018

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221948
Sponsor's protocol ID
A5001
Acronym
VANTAGE
Status last verified
Feb 2025
First submitted
8 Oct 2010
Last updated
5 Feb 2025
Data monitoring committee
Yes

Publications

  • Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

    PubMed 26027940

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deep Brain Stimulation in people with Idiopathic Parkinson's Disease, run by Boston Scientific Corporation at 7 sites in 6 countries.

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 9 inclusion and 15 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, Austria, France, Germany, Italy and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications). (time frame: 26 weeks post first lead implantation). 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 NCT01221948, 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 5 Feb 2025.

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