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VANTAGE is a prospective, multi-center, open-label study that evaluates a new multiple source, constant-current rechargeable system for Deep Brain Stimulation (DBS) in Parkinson's disease.
The objective of the VANTAGE study is to document patient outcomes including effectiveness and safety of bilateral stimulation of the subthalamic nucleus (STN) using the implantable Vercise DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic Parkinson's disease.
In the VANTAGE study, patients implanted with the Vercise system achieved a 63% reduction in meds-off UPDRS-III at 6 months, an effect which was sustained at 1 year post-implant.
Over the course of the VANTAGE study, patients achieved an 46% increase in ON time without dyskinesia, and a 27% increase in sleep.
This study is the first double-blind assessment comparing stimulation at a shorter pulse width to conventional DBS settings at 60 μs pulse width. The superior therapeutic window at 30 μs suggests that shorter pulse widths may be advantageous for avoiding stimulation-related side effects.
Furthermore, this advantage was achieved while maintaining non-inferior efficacy as measured by UPDRS-III. Exploratory analysis of quantitative measures of rest tremor and bradykinesia similarly did not show a difference between the pulse width settings. The short pulse width setting required less electrical energy delivered to achieve an efficacy threshold, suggesting there may be energy efficiency advantages to those settings.
The CUSTOM study found that stimulation with a lower pulse width broadens the therapeutic window. Boston Scientific's Vercise system is capable of stimulation at frequencies as low as 10 µs.
Patients who received therapy at the lower pulse width setting achieved outcomes equivalent to standard DBS patients.