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  • VANTAGE Trial: Three Year Outcomes of a Prospective, Multi-center Trial Evaluating Deep Brain Stimulation With a New Multiple-source, Constant-current Rechargeable System in Parkinson's Disease

    Final Number:

    F. Alesch; R. Jain; L. Chen; T. Brucke; F. Seijo; E. Suarez-San Martin; V. Visser-Vandewalle; M. Barbe; S. Gill; A. Whone; M. Porta; D. Servello; L. Timmermann

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2016 Annual Meeting

    Introduction: DBS has been demonstrated to be effective for Parkinson's disease (PD) symptom relief (Limousin P., et al. 1995). We sought to characterize the benefit of subthalamic nucleus (STN) Deep Brain Stimulation (DBS) for PD patients using a recently CE-marked multiple-source, constant-current system that permits a well-defined distribution of applied current. We report the three year results of the first clinical trial employing multiple independent current control (MICC) DBS in the management of symptoms of Parkinson's disease.

    Methods: VANTAGE is a monitored, prospective, multi-center, non-randomized, open-label interventional trial sponsored by Boston Scientific Corporation. Forty subjects with idiopathic Parkinson's disease (PD) were implanted bilaterally with a DBS system (Vercise) targeting the STN and followed up to three years post-lead placement. Motor improvement was evaluated using UPDRS III scores in stim ON/meds OFF as compared with pre-operative scores. Other assessments such as CAPSIT motor tests, Tremor Rating Scale, Dyskinesia Rating Scale, PDQ-39, SF-36, Schwab and England, and resource utilization were administered. Patient motor diaries were collected over 3 days. Adverse events were also recorded.

    Results: This study will report the safety and effectiveness outcomes of VANTAGE subjects at 3 years post-implantation as compared with baseline.

    Conclusions: The VANTAGE trial is the first reported trial of a multiple-source, constant-current rechargeable system for use in the management of PD symptoms. Study outcomes will inform clinicians on the use of this system and its flexibility to manage the symptoms of idiopathic Parkinson's disease.

    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: The VANTAGE study assesses 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: Limousin P., et al. Mov Disord. 1995 Sep;10(5):672-4.

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