Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE...

Area of Science:

• Neurology
• Neurosurgery
• Biomedical Engineering

Background:

• High-frequency deep brain stimulation (DBS) using a single electrical source is established for Parkinson's disease (PD) motor symptom relief.
• A novel hypothesis proposed that a multiple-source, constant-current DBS device could enhance motor improvement in PD patients.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel implantable multiple-source, constant-current DBS system for Parkinson's disease motor symptom management.
• To assess the impact of this advanced DBS technology on the Unified Parkinson's Disease Rating Scale Part III (UPDRS III) scores.

Main Methods:

• A prospective, multicenter, open-label study (VANTAGE) involving 53 patients with idiopathic Parkinson's disease across six European centers.
• Participants received bilateral subthalamic nucleus implantation of an eight-contact, rechargeable DBS system.
• Primary endpoint: mean change in UPDRS III scores from baseline to 26 weeks post-implantation, assessed in a medication-off state.

Main Results:

• Significant motor symptom improvement observed, with a mean reduction of 23.8 points in UPDRS III scores at 26 weeks (p<0.0001).
• Forty patients completed the primary endpoint analysis, demonstrating sustained efficacy.
• The system exhibited an acceptable safety profile, with most adverse events being mild and transient; three serious adverse events were device/procedure-related and resolved fully.

Conclusions:

• The multiple-source, constant-current DBS system effectively suppressed motor symptoms in Parkinson's disease patients.
• The device demonstrated an acceptable safety profile, warranting further investigation into its long-term benefits and side-effect profile.