Table 2 Pre-determined study stoppage rules

1

Occurrence of one or more SAEs with unexplained etiology and unsatisfactory resolution

2

Occurrence of one or more persistent and debilitating stimulation-related AEs in the CnF

3

Occurrence of hemorrhage, stroke, or paralysis related to device

4

Occurrence of changes in blood pressure, heart rate, and/or respiratory rate related to device function that occur outside of the clinic and require medical intervention

5

Significant worsening of any symptom of PD, other than transiently, including tremor, bradykinesia, rigidity, or gait that would not otherwise have been expected as part of the natural course of the disease