FDA Approves ‘Self-Adjusting’ DBS Therapy for Parkinson Disease

On Monday, the United States Food and Drug Administration (FDA) approved an adaptive deep brain stimulation (aDBS) technology for people living with Parkinson disease (PD).

The technology, to be marketed as BrainSense by manufacturer Medtronic, includes a “self-adjusting” design that allows the therapy to be adjusted in real time based on a patient’s neural activity.

The approval was informed by early findings from the ADAPT-PD trial, a global, multicenter, prospective, single-blind, randomized crossover study that compared chronic dual- and single-threshold adaptive DBS modes with continuous DBS for eligible PD patients. Authors found that aDBS could detect neural signals in both “on” and “off” medication states, regardless of the patient’s particular PD phenotype.

>>NEWS: Propranolol Reduces Tremors in Parkinson Disease Patients

"For patients who struggle with motor symptom fluctuations, dyskinesias, and other side effects with cDBS, aDBS may offer improved symptom control," said Todd Herrington, MD, PhD, director of the Deep Brain Stimulation Program at Massachusetts General Hospital, assistant professor of neurology at Harvard Medical School, and investigator for the ADAPT-PD trial. "Approval of this therapy represents an important step forward for patients and I look forward to seeing the ADAPT-PD study results published soon."

The FDA approval also covers the Medtronic BrainSense Electrode Identifier (EI), designed to reduce the amount of time patients spend in clinic to program DBS settings. A study published in Movement Disorders in 2024 demonstrated that “clinicians can conduct an accurate and precise initial programming 85% faster compared to traditional electrode selection.”

The BrainSense adaptive DBS and EI are currently available in Europe and will be available at select healthcare systems in the United States in the coming weeks; a nationwide rollout will begin in the coming months.

Full results from the ADAPT-PD trial are expected in mid-2025.

References

George J. FDA approves adaptive deep brain stimulator for Parkinson’s disease. MedPage Today. Published online February 24, 2025. Accessed February 25, 2025.

Medtronic earns US FDA approval for the world’s first adaptive deep brain stimulation system for people with Parkinson’s. News release. Medtronic. Published online February 24, 2025. Accessed February 24, 2025.

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. npi Parkinsons Disease. 2024;10. doi: 10.1038/s41531-024-00772-5