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  • Five Year Outcomes of a Prospective, Multicenter Trial Evaluating Deep Brain Stimulation with a New Multiple Source, Constant Current Rechargeable System in Parkinson's Disease

    Final Number:
    666

    Authors:
    Lars Timmermann; Roshini Jain; Nic Van Dyck; Lilly Chen; Thomas Brucke; Fernando Siejo; Esther Suarez-San Martin; Veerle Visser-Vanderwalle; Michael T. Barbe; Steven Gill; Alan Whone; Mauro Porta; Domenico Servello; François Alesch

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2018 Annual Meeting

    Introduction: We postulated that a multiple source, constant current Deep Brain Stimulation (DBS) device permitting a well defined distribution of current would lead to motor improvement in patients with Parkinson’s disease (PD). We previously reported highly significant improved motor function (p <0.0001) as assessed by UPDRS III "meds off" at 6 months post first lead implant as compared with Baseline "meds off," thereby successfully achieving the primary endpoint of this study (1). Here we present the five year, long-term follow up data from the VANTAGE clinical study assessing a DBS system with multiple independent current control (MICC) in the management of symptoms of Parkinson's disease.

    Methods: VANTAGE is a prospective, multicenter, nonrandomized, open label trial sponsored by Boston Scientific. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise, Boston Scientific) targeting the subthalamic nucleus and followed up to five years post lead placement. Assessments included UPDRS III scores in the meds off condition, quality of life such as Parkinson's Disease Questionnaire (PDQ39), Modified Schwab and England (SE), etc. Adverse events were collected.

    Results: At four years post-lead placement, quality of life as assessed by PDQ39, SE continued to show improvement as compared to baseline. Additionally, the usage of antiparkinsonian medications continued to show a similar trend as reported earlier. This report will present the long term motor outcomes and quality of life results at 5 years post lead placement.

    Conclusions: The collected outcomes from the VANTAGE clinical trial will inform clinicians on use of this system, and its flexibility to manage symptoms of idiopathic PD.

    Patient Care: The study outcomes will inform clinicians on the use of a multiple-source, constant-current system and its flexibility to manage the symptoms of idiopathic Parkinson's disease.

    Learning Objectives: By the conclusion of this session, participants should be able to understand the 5 year outcomes of the VANTAGE clinical study assessing the motor improvement in moderate-to-severe Parkinson's disease (PD) following bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) using a new, implantable, rechargeable, multiple-source, 16-output (supporting two 8-contact leads), constant-current DBS System.

    References: 1. Timmermann L., et al. Lancet Neurology 2015 Jul;14(7):693-701.

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