FDA Approves Deep Brain Stimulation Systems for Parkinson Disease
The Food and Drug Administration (FDA) has approved the BrainSense Adaptive Deep Brain Stimulation (DBS) technology and the BrainSense Electrode Identifier (EI) system (Medtronic, Minneapolis, MN) for the treatment of people with Parkinson disease (PD). BrainSense Adaptive DBS updates the Percept DBS platform using brain-computer interface (BCI) technology to enable more individualized neurostimulation with the ability to respond in real time to a patient’s brain activity, reducing the need for manual intervention when treating PD symptoms. The BrainSense EI system is designed to shorten the initial DBS programming time using real-time brain signal analysis to identify optimal electrode settings.
The benefits of adaptive DBS were recently evaluated in the ADAPT-PD clinical trial (NCT04547712). This prospective, single-arm, randomized, crossover study was conducted across 10 centers in the United States, Europe, and Canada, enrolling a total of 68 participants with PD and bilaterial DBS in the primary cohort. The study analysis compared the safety and effectiveness of chronic single- and dual-threshold adaptive DBS using the Medtronic Percept PC system and BrainSense technology compared with continuous DBS. The methods and sensing data from the study were published in npj Parkinson’s Disease, with the publication of results forthcoming.
"Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson's disease," said Helen Bronte-Stewart, MD, MSE, FAAN, FANA, John E. Cahill Family Professor in the department of Neurology and Neurological Sciences and Director of the Human Motor Control and Neuromodulation Lab at Stanford University School of Medicine. "The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs."
Both BrainSense Adaptive DBS and BrainSense EI are available in Europe, and according to a statement by Medtronic, these systems are expected to become available in the US in 2025.