Objective: To evaluate the four year, long-term follow up results of patients in the VANTAGE clinical study that employed multiple independent current control (MICC) Deep Brain Stimulation (DBS) in the management of symptoms of Parkinson’s disease.

Background: A DBS device that enables current fractionalization using a multiple-source mode of delivery can permit the application of a well-defined, shaped electrical field. Thus, we postulated that a multiple-source, constant-current device (CE marked) that permits a well-defined distribution of current would lead to motor improvement in patients with Parkinson’s disease (PD). Previously, results from the VANTAGE clinical study demonstrated 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 study primary endpoint. Here we present the four year, long term results.

Methods: VANTAGE is a prospective, multi-center, non-randomized, open-label trial sponsored by Boston Scientific Corporation. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise) targeting the subthalamic nucleus and followed up to three years post-lead placement. Assessments measured up to 3 years post-lead placement included the following: Levodopa Equivalent Dose (LED), Parkinson’s Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and Modified Schwab and England (SE) scores.

Results: Data from three years post-lead placement has been collected and analyzed.  Anti-parkinsonian medications were found to have remained stable (average of 1399 mg at baseline versus average of 699 mg at 3 years follow up). PDQ-39 summary index scores demonstrate continued improvement (versus baseline values) in quality of life based on assessments of bodily discomfort, activity of daily living, mobility,  emotional well-being, and stability of cognition.  Further, a high proportion of GIC responses were characterized as “improved” (Clinician: 88.2% ; Subject: 82.4%), and modified Schwab and England scores remained stable. Results from 4 years post-lead placement to be presented.

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

References: Timmermann L et al. 18th International Congress of Parkinson’s Disease and Movement Disorders, 2014.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/four-year-outcomes-of-a-prospective-multi-center-trial-evaluating-deep-brain-stimulation-with-a-new-multiple-source-constant-current-rechargeable-system-in-parkinsons-disease/