The VANTAGE Study
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.
Watch the VANTAGE primary investigators speak about the trial.
The CUSTOM-DBS Study
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.
- Timmermann et al. (2015). Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson’s disease (the VANTAGE study): a non-randomized. prospective, multicentre, open-label study. Lancet Neurology. 14: 693-703.
- Volkmann et al. Deep Brain Stimulation at Short Pulse Width Results in Superior Therapeutic Windows for Treatment of Parkinson’s Disease: a Randomized, Controlled, Double-Blind Trial (CUSTOM-DBS). Presented at MDS 2014.