The development of an implantable deep brain stimulation device with simultaneous chronic electrophysiological recording and stimulation in humans.

Deep brain stimulation (DBS) is used to treat a wide array of neurologic conditions. However, traditional programming of stimulation parameters relies upon short term subjective observation of patient symptoms and undesired stimulation effects while in the clinic. To gain a more objective measure of the neuronal activity that contributes to patient symptoms and response to treatment, there is a clear need for a fully-implantable DBS system capable of chronically recording patient-specific electrophysiological biomarker signals over time. By providing an objective correlate of a patient's disease and response to treatment, this capability has the potential to improve therapeutic benefit while preventing undesirable side effects. Herein, the engineering and capabilities of the Percept PC, the first FDA-approved, fully-implantable DBS device capable of nearly-simultaneous electrophysiological recordings and stimulation, are discussed. The device's ability to chronically record local field potentials (LFPs) at implanted DBS leads was validated in patients with neurological disorders. Lastly, the electrophysiological activity correlates of clinically relevant patient-reported events are presented. While FDA approved for conditions such as Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy, chronic electrophysiological recordings in humans has broad applications within basic science and clinical practice beyond DBS, offering a wealth of information related to normal and abnormal neurophysiology within distinct brain areas.