Sleep-Aware Adaptive Deep Brain Stimulation Control: Chronic Use at Home With Dual Independent Linear Discriminate Detectors

Adaptive deep brain stimulation (aDBS) is a promising new technology with increasing use in experimental trials to treat a diverse array of indications such as movement disorders (Parkinson's disease, essential tremor), psychiatric disorders (depression, OCD), chronic pain and epilepsy. In many aDBS trials, a neural biomarker of interest is compared with a predefined threshold and stimulation amplitude is adjusted accordingly. Across indications and implant locations, potential biomarkers are greatly influenced by sleep. Successful chronic embedded adaptive detectors must incorporate a strategy to account for sleep, to avoid unwanted or unexpected algorithm behavior. Here, we show a dual algorithm design with two independent detectors, one used to track sleep state (wake/sleep) and the other used to track parkinsonian motor state (medication-induced fluctuations). Across six hemispheres (four patients) and 47 days, our detector successfully transitioned to sleep mode while patients were sleeping, and resumed motor state tracking when patients were awake. Designing "sleep aware" aDBS algorithms may prove crucial for deployment of clinically effective fully embedded aDBS algorithms.