CompletedNCT01221948VANTAGEUpdated Feb 5, 2025Results posted

Vercise Implantable Stimulator for Treating Parkinson's Disease

A Phase 2 interventional study of Deep Brain Stimulation in Idiopathic Parkinson's Disease, sponsored by Boston Scientific Corporation. Completed at 7 sites in 6 countries. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Boston Scientific Corporation · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 53
Allocation: Not applicable
Ages: 21 Years to 75 Years
Sex: All

Study 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 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).

Conditions studied

Idiopathic Parkinson's Disease

Browse trials for

Parkinson Disease 4,487

Keywords

Deep Brain Stimulation
Parkinson's Disease

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 53 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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.
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.

Key Exclusion Criteria:

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).
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 53 participants (actual)

Study arms

Experimental
Deep Brain Stimulation
Rechargeable Deep Brain Stimulation System
Device: Deep Brain Stimulation

Interventions

DeviceDeep Brain Stimulation
Rechargeable Deep Brain Stimulation System

What researchers measure

Primary outcomes

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.
Time frame: 26 weeks post first lead implantation

Secondary outcomes

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.
Time frame: 12 and 52 weeks post first lead implantation
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
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
Time frame: 12, 26 and 52 weeks post first lead implantation
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
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.
Time frame: 12, 26 and 52 weeks post first lead implantation
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).
Time frame: 12, 26 and 52 weeks post first lead implantation
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.
Time frame: 52 weeks post first lead implantation

Results

Posted Nov 13, 2015

Participant flow

Subjects recruited at 6 European centers for the study

Participant flow — Overall Study
Milestone	Deep Brain Stimulation
Started	53
Completed	39
Not completed	14
Withdrew: Physician decision	5
Withdrew: Withdrawal by subject	2
Withdrew: Not disclosed	2
Withdrew: Death	1
Withdrew: Protocol violation	4

Outcome measures

SecondaryMean 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.

Time frame:: 12 and 52 weeks post first lead implantation
Reported as:: Mean · units on a scale

Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
units on a scale	Deep Brain Stimulation
Mean Change from Baseline to Week 12	-22.3 ± 8.05
Mean Change from Baseline to Week 52	-23.7 ± 8.83

SecondaryMean 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.

Time frame:: 12, 26 and 52 weeks post first lead implantation
Reported as:: Mean · units on a scale

Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
units on a scale	Deep Brain Stimulation
Change from Baseline to 12 weeks	-10.5 ± 7.76
Change from Baseline to 26 weeks	-11.8 ± 5.96
Change from Baseline to 52 weeks	-10.1 ± 8.55

SecondaryMean 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

Time frame:: 12, 26 and 52 weeks post first lead implantation
Reported as:: Mean · mg

Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
mg	Deep Brain Stimulation
Change from Baseline to 12 weeks	-683.126 ± 537.91
Change from Baseline to 26 Weeks	-740 ± 603.6
Change from Baseline to 52 weeks	-816 ± 571.4

SecondaryMean 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.

Time frame:: 12, 26 and 52 weeks post first lead implantation
Reported as:: Mean · hours/day

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.
hours/day	Deep Brain Stimulation
Change from Baseline to 12 weeks in ON time	3.1 ± 7.3
Change from Baseline to 26 weeks in ON time	3 ± 6.31
Change from Baseline to 52 weeks in ON time	3.5 ± 6.58

SecondaryMean 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.

Time frame:: 12, 26 and 52 weeks post first lead implantation
Reported as:: Mean · percentage change

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.
percentage change	Deep Brain Stimulation
Percent Change from Baseline to 12 Weeks	-38 ± 41.2
Percent Change from Baseline to 26 Weeks	-29 ± 39
Percent Change from Baseline to 52 Weeks	-34.5 ± 45.6

SecondaryMean 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).

Time frame:: 12, 26 and 52 weeks post first lead implantation
Reported as:: Mean · percentage change

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
percentage change	Deep Brain Stimulation
Percent Change from baseline to 12 weeks	9 ± 21
Percent Change from baseline to 26 weeks	12 ± 26.2
Percent Change from Baseline to 52 weeks	12.5 ± 23.4

PrimaryMean 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
Reported as:: Mean · units on a scale

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).
units on a scale	Deep Brain Stimulation
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).	-23.8 ± 10.59

SecondaryPercentage 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.

Time frame:: 52 weeks post first lead implantation
Reported as:: Number · percentage of participants

Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
percentage of participants	Deep Brain Stimulation
Percent Improved at 52 weeks	97.4
Percent with no change at 52 weeks	0
Percent worsened at 52 weeks	2.6

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Deep Brain Stimulation	—	10/40 (25%)	37/40 (92.5%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Deep Brain Stimulation
InfluenzaInfections and infestations	2/40
CystitisInfections and infestations	1/40
Helicobacter gastritisInfections and infestations	1/40
Implant site infectionInfections and infestations	1/40
Localised infectionInfections and infestations	1/40
PneumoniaInfections and infestations	1/40
Staphylococcal infectionInfections and infestations	1/40
Device migrationInjury, poisoning and procedural complications	1/40
FallInjury, poisoning and procedural complications	1/40
Joint sprainInjury, poisoning and procedural complications	1/40

Most frequent other events

Showing 10 of 75

Most frequent other events
Event	Deep Brain Stimulation
FallInjury, poisoning and procedural complications	9/40
DepressionPsychiatric disorders	6/40
Hand fractureInjury, poisoning and procedural complications	3/40
Restless legs syndromeNervous system disorders	3/40
ApathyPsychiatric disorders	3/40
Head injuryInjury, poisoning and procedural complications	2/40
Skeletal injuryInjury, poisoning and procedural complications	2/40
DystoniaNervous system disorders	2/40
ParaesthesiaNervous system disorders	2/40
Speech disorderNervous system disorders	2/40

Baseline characteristics

40 enrolled subjects who met study eligibility were implanted with the Vercise DBS system.

Age, Customized
Age, Customized(participants)	Deep Brain Stimulation
<=60 years	19
61-70 years	18
>70 years	3

Sex: Female, Male
Sex: Female, Male(Participants)	Deep Brain Stimulation
Female	13
Male	27

Region of Enrollment
Region of Enrollment(participants)	Deep Brain Stimulation
France	1
Spain	11
Austria	12
Germany	9
United Kingdom	6
Italy	1

Study locations

7 sites

Allgemeines Krankenhaus AKH
Vienna, Austria
CHU de Rennes-Pontchaillou
Rennes, France
Uniklinik Köln
Cologne, Germany
IRCCS Istituto Ortopedico Galeazzi
Milano, Italy
Hospital Central de Asturias
Oviedo, Spain
Frenchay Hospital
Bristol, United Kingdom
Southmead Hospital Bristol
Bristol, United Kingdom

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01221948
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Oct 18, 2010
Start date: Oct 2010
Primary completion: May 2013
Completion: Jun 1, 2018
Results posted: Nov 13, 2015
Last update: Feb 5, 2025

Study contacts

Lars Timmermann, M.D.

principal investigator · Universitätsklinikum Köln

François Alesch, M.D.

principal investigator · Allgemeines Krankenhaus AKH, Vienna, Austria

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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