Anodic Stimulation in Parkinson's Disease

Randomized Crossover Trial of Chronic Anodic Versus Cathodic Stimulation in Parkinson's Disease Patients.

Randomized, double-blind, crossover design, interventional study to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, symptom control, and quality of life in Parkinson's Disease patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.

Prior studies and literature have suggested that directional leads might enable the use of complex bipolar configurations to activate neurons within a target and avoid side effects based on knowledge of local fiber tracts. The Boston Scientific Vercise system offers a unique opportunity to test this hypothesis. The Cartesia lead is a directional lead with 4 levels of contact, the middle 2 which are segmented, while the Vercise Genus generators utilize multiple independent current sources connected to each contact. This combination enables complex, highly customizable stimulation configurations, which can be incrementally adjusted in real time, without recourse to shutting the device off between parameter changes. This study proposes to utilize this technology to compare pure cathodic, pure anodic, and mixed cathodic/anodic stimulation in patients with Parkinson's Disease implanted with STN-DBS leads. The primary objective is to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, minimum current amplitude that activates side effects inducing the pyramidal tract, symptom control, and quality of life in Parkinson's Disease (PD) patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.

Inclusion Criteria:

• Patients that are between the ages of 40-80 years of age.
• Patients diagnosed with Idiopathic Parkinson's Disease that are treated with bilateral STN DBS Boston Scientific Vercise Cartesia directional leads for at least 3 months.
• Patients whose DBS settings can be optimized to include anodic and cathodic stimulation.

Exclusion Criteria:

• Parkinson's Disease patients implanted with DBS leads outside of FDA labeling.
• Patients who are not chronically using anodic stimulation parameters.