Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Key Inclusion Criteria:

• Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
• Be at least 18 years of age.
• Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key Exclusion Criteria:

• Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.