Study Rationale:
The side effects of deep brain stimulation (DBS) in Parkinson’s disease are related to overstimulation of the brain target structure and neighboring regions. This clinical study seeks to improve outcomes by controlling the direction of the electrical current in the brain using a novel directional DBS electrode lead. This approach offers more precise current delivery, requires less current, is more forgiving for lead placement, and promotes longer neurostimulator battery life.
Hypothesis:
Directional DBS will provide improved clinical outcomes when compared to standard-of-care DBS electrodes.
Study Design:
The proposed clinical trial is a single-arm study in 59 patients measuring the average change of UPDRS III (United Parkinson’s Disease Rating Scale Section III) between baseline pre-operative and at six months post-operative. The secondary endpoints are an increase in therapeutic window (difference in current required to achieve sustained side effects minus the current required for full beneficial effect) and a decrease in the therapeutic current required.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
The use of more sophisticated neuromodulation devices and methods hold the potential to greatly improve clinical outcomes for Parkinson’s patients undergoing DBS, providing more precise surgical interventions, less post-operative care and a decrease in side effects.
Next Steps for Development:
The study will serve to statistically compare this novel neuromodulation approach with existing systems and will conclude with market clearance for the device in Europe.