MILAN, Feb. 4, 2021 /PRNewswire/ -- Newronika, a spin-off of the world-class neurological research center Policlinico of Milan and University of Milan, today announced the first patient implanted with the AlphaDBS adaptive closed-loop deep brain stimulation (aDBS) system. Closed-loop stimulation is the most important advancement in the DBS field to date.
Newronika has initiated a multi-center clinical trial to evaluate the AlphaDBS adaptive closed-loop system in patients with Parkinson's disease. The first implant was performed at Department of Neurosurgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland by Professor Tomasz Mandat.
The neuronal activity recorded in the first patient with Parkinson's disease 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 different investigational clinical trials.
AlphaDBS is a unique deep brain stimulation system that 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. Current DBS systems deliver constant stimulation to the brain, 24 hours per day, even when it may not be necessary. Constant stimulation either delivers too much, too little or just the right amount of electrical current but only randomly regardless of the patient's clinical state fluctuations.
Real time sensing and recording will enable Newronika to rapidly build a large dataset of bioelectrical signals, the Newronika WebBioBank. Data will be uploaded through an App connected to the implanted device via Bluetooth. The unique web platform is a bridge between patients and neurologists. The technology opens new avenues of research to develop new indications and explore new opportunities.
"Adaptive stimulation and closing the loop is a patient-centered approach to treating Parkinson's disease. 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," said Lorenzo Rossi, PhD, co-founder and CEO of Newronika.
"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. Cardiology did this 40 years ago with pacemakers. It's past time we closed the loop for the brain," according to Alberto Priori, MD, Professor of Neurology at the University of Milan and Chair of Newronika's Scientific Advisory Board".
About Parkinson's Disease
Parkinson's disease is a neurodegenerative disease in which cells in a part of the brain called the substantia nigra deteriorate and thereby reduce the amount of dopamine, a neurotransmitter important for movement and many other functions. According to the Parkinson's Foundation as many as 1 million people in the United States are affected and 10 million worldwide. The cause remains unknown. Symptoms include slowness of movement, tremor, stiffness and poor balance.
About Deep Brain Stimulation
Deep brain stimulation is an approved, safe and effective treatment for patients with advanced Parkinson's disease that cannot be adequately controlled with medications. It involves surgically implanted electrodes in specific regions of the brain which are connected to an implantable device similar to a pacemaker. Over 175,000 people worldwide have received DBS systems.
About Newronika S.p.A.
Newronika (www.newronika.com) is the spin-off company of two of the world-leading research institutions in the field of Neurology, the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and the University of Milan. Newronika restores brain and body functions with its innovative technology, translating their deep knowledge of bio-signal decoding into clinical practice with the aim of developing new treatments and improve existing ones. Newronika comprises a multidisciplinary team involving neurophysiology, neurology, biomedical engineering, neuropsychology, bioinformatics, and biotechnologies.
SOURCE Newronika S.r.l