MILAN—Newronika S.p.A., a spin-off from the world-class neurological research center Policlinico of Milan and the University of Milan, has reported that the company has implanted its first patient with the AlphaDBS adaptive closed-loop deep brain stimulation (aDBS) system. Closed-loop stimulation is said to be the most important advancement in the DBS field to date.
Deep brain stimulation is an approved, safe, and effective treatment for patients with advanced Parkinson’s disease which can’t be adequately controlled with medications. It involves surgically implanting electrodes in specific regions of the brain, which are connected to an implantable device similar to a pacemaker. Current DBS systems deliver constant stimulation to the brain, 24 hours a day. Constant stimulation either delivers too much, too little, or the correct amount of electrical current, but only randomly — regardless of the patient’s fluctuations in clinical state.
Newronika has now initiated a multi-center clinical trial to evaluate their AlphaDBS adaptive closed-loop system in patients with Parkinson’s. The first implant was performed by Professor Tomasz Mandat at the Department of Neurosurgery in the Maria Sklodowska-Curie National Research Institute of Oncology, located in Warsaw, Poland.
The neuronal activity recorded in this first patient from the fully implanted system confirms the intended performance of the AlphaDBS system. The data, collected using the implanted system, corroborate previous findings from studies of 48 patients using an external system in three separate investigational clinical trials.
“Adaptive stimulation and closing the loop is a patient-centered approach to treating Parkinson's disease,” said Dr. Lorenzo Rossi, co-founder and CEO of Newronika. “Symptoms fluctuate over the course of the day, and it is important to adapt treatment accordingly. Too much stimulation uses power unnecessarily, and doesn’t give the neurons a chance to rest. Too little is not effective.”
AlphaDBS continuously records and interprets bioelectrical neuronal activity in the brain where stimulation is delivered. The proprietary sensing technology records noise-free local field potentials while electrical stimulation is delivered, and adapts the amount of electrical current delivered to meet the individual needs of each patient at any given moment.
Real-time sensing and recording will enable Newronika to rapidly build a large dataset of bioelectrical signals for the company’s WebBioBank. Data will be uploaded through an app connected to the implanted device via Bluetooth. This technology will hopefully open new avenues for developing new indications, and exploring new research opportunities.
“DBS is an established treatment for Parkinson’s disease, but there has been minimal innovation over the years. The ability to close the loop is the most important advancement in the last 25 years. The potential to improve outcomes and make patient management simpler is a major innovation,” noted Dr. Alberto Priori, professor of Neurology at the University of Milan, and chair of the scientific advisory board at Newronika. “Cardiology did this 40 years ago with pacemakers. It’s past time we closed the loop for the brain.”