FDA Approves Medtronic’s Adaptive Deep Brain Stimulation for Parkinson Disease

Brett Wall

According to a new announcement, the FDA has granted approval to Medtronic’s Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), marking a significant advancement in personalized care for patients with Parkinson disease (PD).¹

The decision comes less than 2 months after the European Union gave CE Mark approval for the pair of digital modalities to be used in PD care. Each technology is a bit different: aDBS dynamically adjusts DBS in real-time based on patient-specific brain activity whereas the EI optimizes initial DBS programming by precisely identifying the strongest signal location. Research has shown that through EI, clinicians can conduct more accurate and precise initial programming that is 85% faster than traditional electrode selection.

"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, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy," Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio, said in a statement.¹

The ADAPT-PD trial (NCT04547712), the largest and longest assessment of aDBS conducted in both clinical and home settings, served as major support for the FDA decision. Published in npj Parkinson’s Disease, the interventional, prospective, single-blind, randomized crossover study featured 68 patients with either subthalamic nucleus (STN) or globus pallidus internus (GPi) DBS leads connected to a Medtronic Percept PC neurostimulator.²

During the enrollment and screening procedures, a local field potential (LFP; 8-30 Hz; ≥1.2 uVp) control signal was identified by clinicians in 84.8% of patients on medication (65% bilateral signal), and in 92% of patients off medication (78% bilateral signal). Additionally, frequency of the peak LFP had the largest shift from medication ON to OFF state in the alpha band (21.2% on medication, 31% off medication). Consequently, investigators concluded that detection of an LFP signal may be sufficient for aDBS programming in the large majority of patients without necessitating medication withdrawal.

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In the study, LFP peak detection met inclusion criteria in 84% (57/68) of participants, including 78% of STN patients (40/51) and all GPi patients (17/17). LFP peaks in the STN were distributed across alpha (15.3% on medication, 19.7% off), low-beta (43.1% on, 43.7% off), and high-beta (41.7% on, 36.6% off) ranges, while GPi peaks were found in alpha (37% on, 58.6% off), low-beta (37% on, 10.3% off), and high-beta (25.9% on, 31% off) ranges. Using an automated off-line detection algorithm, 56.3% of LFP peaks were identified in 63 participants (126 nuclei), with similar detection rates for both STN (53/94, 56.4%) and GPi (18/32, 56.3%). The most frequently detected peaks were in the high-beta range, though low-beta peaks had the greatest power in the grand average, with a frequency of 18.6 ± 6.05 Hz (range 9.8–29.3 Hz).

"Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson disease,” Helen Bronte-Stewart, MD, 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, said in a statement.¹ "The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs."

DBS is considered a well-established treatment for PD, typically used in patients with advanced disease who no longer respond optimally to medication or experience significant motor fluctuations. Traditional DBS delivers continuous, fixed-frequency stimulation, regardless of changes in patient’s symptoms, motor states, or medication levels. While effective, this approach does not take into account fluctuations in the patient’s condition, which can result in suboptimal therapeutic effects, adverse events, or energy inefficiencies.

aDBS is a newer, dynamic approach designed to address these limitations. Rather than providing constant stimulation, adaptive DBS adjusts in real-time based on the patient's brain activity. This is achieved through the use of closed-loop systems, where the DBS system monitors brain signals (such as local field potentials or LFPs) and adjusts stimulation parameters (e.g., intensity, frequency) accordingly. For example, the system may increase or decrease stimulation depending on detected symptoms like tremor or bradykinesia, potentially improving therapeutic outcomes, reducing side effects, and conserving battery life.

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 24, 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 RL, 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. 2024;10:174. doi:10.1038/s41531-024-00772-5