Vercise Implantable Stimulator for Treating Parkinson's Disease

NCT01221948 | Completed Phase 2 Results DMC

• 1 other identifier: A5001
• Study Type: interventional
• Target: 53
• Locations: 6 countries
• Sites: 7

Brief 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).

Conditions

Idiopathic Parkinson's Disease

Keywords

Deep Brain Stimulation; Parkinson's Disease

Outcome Measures

Primary Outcomes (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.

  26 weeks post first lead implantation

Secondary Outcomes (7)

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

  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.

  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

  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.

  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.

  12, 26 and 52 weeks post first lead implantation

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Rechargeable Deep Brain Stimulation System

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Rechargeable Deep Brain Stimulation System

Deep Brain Stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Allgemeines Krankenhaus AKH

Vienna, Austria

Location

CHU de Rennes-Pontchaillou

Rennes, France

Location

Uniklinik Köln

Cologne, Germany

Location

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Frenchay Hospital

Bristol, United Kingdom

Location

Southmead Hospital Bristol

Bristol, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26027940 DERIVED

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

Results Point of Contact

• Title: Nic Van Dyck, Director International Clinical Operations
• Organization: Bostons Scientific Neuromodulation

vandyckn@bsci.com

+31 43 3568328

Study Officials

• Lars Timmermann, M.D.

  Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

• François Alesch, M.D.

  Allgemeines Krankenhaus AKH, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2018
• Last Updated: February 5, 2025
• Results First Posted: November 13, 2015

Record last verified: 2025-02

Locations

FR (1); IT (1); AU (1); GB (2); ES (1); DE (1)