VANTAGE Trial: A Prospective, Multi-center Trial Evaluating Deep Brain Stimulation with a New Multiple-Source, Constant-Current Rechargeable System in Parkinson’s Disease (P1.173)

OBJECTIVE: study assessed improvement in motor function and overall quality of life in patients with moderate-to-severe Parkinson’s disease (PD) following bilateral subthalamic nucleus deep brain stimulation (DBS) using an implantable, rechargeable, multiple-source, 16-contact, constant-current Vercise DBS system. BACKGROUND: Several randomized controlled trials (Deuschl et al. 2006, Weaver e t al. 2009, Okun et al . 2012) have demonstrated that DBS is an effective treatment for patients with Parkinson’s disease. Motor improvement following DBS is sustained up to 10 years (Castrioto et al. 2011). DESIGN/METHODS: VANTAGE is a, prospective, multi-center, non-randomized, open-label interventional trial, sponsored by Boston Scientific Corporation. 40 subjects with idiopathic Parkinson’s disease (PD) were implanted bilaterally in the subthalamic nucleus (STN). Subjects were followed at 3, 6 and 12 months post lead placement. Motor improvement was evaluated using UPDRS III scores in stim ON/meds OFF as compared with baseline. Other assessments including quality of life such as PDQ-39, SF-36, Schwab and England were administered. Patient motor diaries were collected over 3 days. Adverse events were recorded. RESULTS: highly significant improvement of 62[percnt] in UPDRS III scores at 12 months post implant in stim on/meds off condition was reported. A 35[percnt] improvement in mean PDQ-39 summary index was reported at 12 months post implant driven by improved Activities of Daily Living, Mobility, and Bodily Discomfort. CONCLUSIONS: Highly significant motor improvement, as evaluated using UPDRS III, was demonstrated at 6 months that was further sustained up to 12 months post lead placement. Subjects overall quality of life also improved significantly. The trial is the first reported trial of a multiple-source, constant-current rechargeable system in PD up to 12 months. Study Supported by: Boston Scientific Corporation Disclosure: Dr. Timmermann has received personal compensation for activities with Medtronic, Inc., Boston Scientific Corporation, Bayer Healthcare, and UCB Pharma. Dr. Jain has received personal compensation for activities with Boston Scientific Corporation as an employee. Dr. Brucke has nothing to disclose. Dr. Seijo has nothing to disclose. Dr. Suarez San Martin has nothing to disclose. Dr. Haegelen has nothing to disclose. Dr. Verin has nothing to disclose. Dr. Maarouf has nothing to disclose. Dr. Barbe has nothing to disclose. Dr. Gill has nothing to disclose. Dr. Whone has nothing to disclose. Dr. Porta has nothing to disclose. Dr. Servello has nothing to disclose. Dr. Alesch has nothing to disclose.