FDA OKs First Adaptive DBS System for Parkinson’s Disease

The US Food and Drug Administration (FDA) has approved the first adaptive deep brain stimulation (aDBS) system for Parkinson’s disease (PD) that self-adjusts therapy to individual brain activity in real time. 

Medtronic’s BrainSense aDBS system is currently for use in patients with PD who have been implanted with the Medtronic Percept neurostimulator. 

“Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” Helen Bronte-Stewart, MD, MSE, director of the Stanford Movement Disorders Center and of the Stanford Human Motor Control and Balance Laboratory at Stanford University School of Medicine, California, said in a company news release. 

“The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs,” Bronte-Stewart added. 

Bronte-Stewart served as the global principal investigator for the Medtronic Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial, which evaluated the safety and effectiveness of chronic-dual and single-threshold aDBS modes, as compared to continuous DBS, in patients with PD eligible for the treatment. 

The ADAPT-PD trial results have not yet been published. 

In a small pilot trial published last year in Nature Medicine, personalized aDBS enhanced the control of motor symptoms of PD compared with standard DBS. As previously reported by Medscape Medical News, aDBS reduced the time spent with motor symptoms by half and improved patients’ quality of life compared with standard DBS. 

The FDA’s approval of BrainSense aDBS also includes the Medtronic BrainSense Electrode Identifier, which helps reduce patient time spent in clinic to program their DBS settings. 

“BrainSense Electrode Identifier offers less ambiguity and greater efficiency compared to the traditional method of electrode selection by providing a personalized, real-time snapshot of a patient’s brain signals, which can help provide insights into the proximal sweet spot for programming. This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient,” Drew Kern, MD, MS, neurologist and associate professor of neurology at the University of Colorado School of Medicine, said in the release. 

Medtronic said patient programming utilizing the BrainSense aDBS technology will begin “at select healthcare systems over the coming weeks with availability nationwide in the coming months.”

More information is available online.