FDA Approves New Adaptive DBS System

FDA Approves New Adaptive DBS System

In exciting news, the FDA approved Medtronic’s deep brain stimulation (DBS) system known as BrainSense™. Unlike standard DBS, which delivers electricity to the brain at pre-programmed settings, this technology can sense the brain’s electric signals, known as local field potentials or LFPs, and adjust the stimulation accordingly. This capability, known as adaptive DBS (aDBS), allows the DBS system to respond to the sensed signal and optimize the electricity delivery. Although these sensing electrodes have already been implanted in people, the adaptive capabilities have not been utilized and so far, have only been used as standard electrodes. We recently reported on research into how best to use the sensing mechanisms of the electrodes which was published in Nature Medicine .

Now that the FDA has approved the system, the adaptive capabilities of the system will be used clinically. The system will automatically adjust the DBS stimulation parameters based on a person’s brain activity in real time with the expectation that these adjustments will improve PD symptom control with DBS. The ongoing clinical trial ADAPT-PD trial (NCT04547712) is continuing to evaluate the use of two different ways of delivering adaptive DBS, and comparing it to conventional DBS, in 85 adults with Parkinson’s disease. The study is expected to be completed in October 2025, gathering further evidence of how aDBS can help improve the symptoms of PD.

APDA is excited to see this new era in DBS unfold, with more personalized treatment provided to people with PD, leading to more precise symptom management.

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