FDA approves Medtronic’s adaptive DBS system for Parkinson’s
BrainSense system offers personalized stimulation adjusted in real time
The U.S. Food and Drug Administration (FDA) approved Medtronic’s BrainSense adaptive deep brain stimulation (DBS) system and electrode identifier to treat people with Parkinson’s disease.
Among available DBS systems, BrainSense is the first to automatically adapt its stimulation for a more personalized treatment approach, the company noted. Specifically, it equips the existing Percept DBS stimulator devices — including Percept PC and Percept RC — with BrainSense technology for adaptive function.
“Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real time,” Brett Wall, executive vice president and president of neuroscience portfolio at Medtronic, said in a company press release. “This new era in Parkinson’s care represents more than a decade of intentional innovation — ushering in personalized neuromodulation at scale that responds to a patient’s changing needs … and setting a new standard for DBS therapy.”
DBS can help when medications no longer control disease symptoms
BrainSense also is available in Europe, where it recently earned a CE Mark, which indicates that a product meets required safety, health, and environmental protection standards.
BrainSense is available to Parkinson’s patients already using a Percept neurostimulator to help manage their disease, as well as those newly eligible for DBS. Programming of patient devices in the U.S. will begin in select healthcare systems over the coming weeks, before becoming more widely available, according to Medtronic.
DBS is an established surgical treatment of Parkinson’s for patients whose disease motor symptoms are not adequately controlled by standard Parkinson’s medications.
In this treatment approach, a neurostimulation device similar to a pacemaker is implanted under the skin and connected to electrodes that are surgically placed in targeted brain regions, where they deliver light electrical pulses. Its goal is to offset the abnormal brain signaling patterns that drive Parkinson’s symptoms.
Most available DBS systems deliver constant stimulation regardless of a person’s symptoms at any given moment, and they require device programming over time to deliver optimal stimulation, which can involve a lengthy trial-and-error process.
Recorded brain signals are analyzed to adjust needed stimulation
As an adaptive DBS system, BrainSense is designed to automatically adjust its output based on a person’s brain activity in real time, providing more personalized symptom control. It relies on brain-computer interface technology, which allows for a direct communication link between the brain and a device.
Brain signals recorded by the implanted Percept neurostimulator are analyzed by a computer algorithm to determine the degree of needed stimulation. That information then is sent to the device, which delivers the appropriate stimulation.
“Our BrainSense technology provides unique and clinically important insights that no other DBS system can offer, using a person’s own brain signals to provide a window into their condition, in real time, over time,” said Paolo Di Vincenzo, president of neuromodulation business at Medtronic.
The ongoing, global ADAPT-PD trial (NCT04547712) is evaluating the use of two different modes of adaptive DBS, and comparing it to conventional DBS, in 85 adults with Parkinson’s disease.
Early results showed that most patients had symptom-related brain signals strong enough to trigger adaptive DBS regardless of disease severity or the location of placed electrodes.
Electrode identifier, also approved, aims at more efficient programming
“Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease,” allowing “ transformative personalized care … through automatic adjustment,” said Helen Bronte-Stewart, MD, a professor in the department of neurology and neurological sciences at Stanford University School of Medicine, in California, and ADAPT-PD’s global principal investigator.
The FDA also approved Medtronic’s BrainSense electrode identifier, which provides a quick snapshot of a person’s brain activity to help program the device more efficiently.
The identifier, which has been found to be 85% faster than traditional methods, “offers less ambiguity and greater efficiency … [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,” said Drew Kern, MD, a neurologist and associate professor at the University of Colorado School of Medicine.
“This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient,” Kern added.
About the Author
