Adaptive Deep Brain Stimulation Technology Receives FDA Approval for Parkinson Disease

The FDA approved adaptive deep brain stimulation (aDBS) and electrode identifier technology, called BrainSense Adaptive, for people living with Parkinson disease.1 The approval marks a groundbreaking advancement in treating the neurological condition, according to the announcement from Medtronic.

The BrainSense Adaptive DBS system builds upon Medtronic's proprietary technology.

image credit: Werckmeister - stock.adobe.com

Supporting data provided extensive clinical validation through the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial. The international study demonstrated the safety and efficacy of adaptive DBS compared with traditional continuous DBS methods. The BrainSense Adaptive DBS system builds upon Medtronic's proprietary BrainSense technology, which detects, captures, and classifies various brain signals essential for effective therapy.

“Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson's disease. The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs,” lead investigator Helen Bronte-Stewart, MD, MSE, of the department of Neurology and Neurological Sciences and Director of the Human Motor Control and Neuromodulation Lab at Stanford University School of Medicine, stated.

In addition to BrainSense Adaptive DBS, the approval includes the BrainSense electrode identifier, streamlining the DBS programming process with enhanced precision and efficiency. According to the statement, this tool reduces initial programming time by 85% compared with traditional methods, offering tailored therapy delivery from the outset. The ADAPT-PD trial is the largest and longest assessment of aDBS in clinical and home settings.

The international, multicenter, prospective, single-blind, randomized crossover study evaluated the safety and efficacy of chronic dual- and single-threshold aDBS modes compared with continuous DBS (cDBS) in eligible patients with Parkinson disease receiving DBS therapy.2 Both modes or algorithms for aDBS investigated in the ADAPT-PD trial have shown efficacious therapy in previous smaller, single-center studies.

The investigators found that single threshold rapidly adjusts stimulation to suppress beta bursts linked to symptoms, while dual threshold adapts more gradually to medication effects, maintaining beta power within a therapeutic window. Dual threshold may help with motor fluctuations on cDBS plus medication, while single threshold can aid those with narrow therapeutic windows and stimulation adverse effects, the study stated.

Similar to a cardiac pacemaker for the brain, DBS involves surgically implanting a neurostimulator that sends electrical signals to targeted brain areas affected by neurological disorders.1 The new technology is available to patients who received Medtronic's Percept neurostimulator implantation.

“For patients who struggle with motor symptom fluctuations, dyskinesias, and other side effects with continuous DBS, adaptive DBS may offer improved symptom control,” ADAPT-PD investigator Todd Herrington, MD, PhD, of Massachusetts General Hospital in Boston, stated. “Approval of this therapy represents an important step forward for patients.”

BrainSense Adaptive DBS and electrode identifier are now available in Europe, with US patient programming launching in select health care systems and expanding nationwide in the coming months.

References

1. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's. News release. Medtronic. February 24, 2025. Accessed February 26, 2025. https://news.medtronic.com/2025-02-24-Medtronic-earns-U-S-FDA-approval-for-the-worlds-first-Adaptive-deep-brain-stimulation-system-for-people-with-Parkinsons

2. Stanslaski S, Summers RLS, Tonder L, et al. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) clinical trial. NPJ Parkinsons Dis. 2024;10(1):174. doi:10.1038/s41531-024-00772-5