The treatment adjusts deep brain stimulation based on real-time signals
Neuromodulation technology developer Newronika has received CE Mark approval for its AlphaDBS device, offering a new treatment option for patients with neurological disorders such as Parkinson’s disease.
AlphaDBS is a closed-loop deep brain stimulation (DBS) system that adjusts stimulation based on real-time brain signals.
"This certification validates our vision of bringing truly adaptive neuromodulation to patients,” said Newronika co-founder and CTO Lorenzo Rossi. “We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson's disease."
While DBS is already a proven therapy for managing symptoms of neurological conditions such as Parkinson’s disease, dystonia, essential tremor and OCD, it currently only delivers continuous stimulation at fixed settings.
Newronika’s Alpha DBS customises DBS therapy by monitoring the patient’s brain activity and automatically adjusting stimulation levels in response to neurophysiological feedback.
AlphaDBS features two recording local field potential (LFP) channels with FilterDBS sensing technology, which can record noise-free LFPs while electrical stimulation is delivered.
This level of real-time personalisation aims to optimise symptom control while reducing side effects and reducing the need for frequent programming adjustments by neurologists.
Clinical trials for AlphaDBS showed the patients spent more time without symptoms and side effects compared to conventional DBS.
The CE Mark approval will bring the AlphaDBS treatment to Europe, offering patients a more dynamic treatment option tailored to their neurophysiological feedback.
