SMART-DBS: A Symptom-Manipulating, Adaptive and Responsive Therapy for continuous brain-behavioral recording and stimulation

About This Grant

Project Summary Obsessive compulsive disorder (OCD) affects approximately 2.2 million adults worldwide, with more than 200,000 cases and a socioeconomic impact exceeding $8 billion in the United States every year. Provisional FDA approval treats OCD by delivering deep brain stimulation (DBS). We propose that real opportunity lies in a vastly underused resource: the chronically implanted brain electrodes. To date, however, ambulatory intracranial electroencephalographic (iEEG) recordings from DBS leads have only been available under very specific conditions and without the benefit of synchronized disease-relevant behavioral monitoring to provide necessary context. The goal of this 5-year milestone-driven clinical trial proposal is to unlock the potential of DBS leads for continuous sensing of brain activity, enabling the real-time tracking of internal states linked to the full spectrum of motor and non-motor symptoms in OCD. Today, long-term continuous brain sensing is not feasible due to limitations in battery life, power delivery, and data transmission bandwidth in existing DBS systems. We aim to overcome these barriers by integrating new telemetry and wireless power solutions into an innovative wearable platform, SMART-DBS, that supports chronic streaming of neural signals along with physiological signals based on muscle activity, heart rate variability and accelerometry to provide additional symptom sensing. We will also collect validated symptom measures via patient-reported outcomes (e.g., digital scales), structured clinical instruments, and app-based logging. By aligning chronic brain recordings with subjective and objective measures of clinical symptoms in OCD, we will link brain states to clinical outcomes. This project develops innovative technologies to directly address the major challenges in brain-behavioral quantification and synchronization in order to enable a follow-up trial to treat OCD using adaptive, responsive DBS. Progress will also indirectly advance a range of next-generation clinical studies of the brain mechanisms of human behavior such as in Parkinsons, epilepsy, depression and other applications of DBS in ambulatory populations.