Newronika Implants First Participant in ADVENT Pivotal Study
News related to:Newronika S.p.A · 2 min read
MILAN, Sept. 30, 2026 /CourierPR/ -- Newronika S.p.A., a medical technology company based in Milan, Italy, has taken a significant step in its quest to advance deep brain stimulation (DBS) therapies for Parkinson's disease. The company announced that the first participant in its pivotal ADVENT study has been implanted with the αDBS® adaptive deep brain stimulation system. The procedure was performed on September 21st at the Hospital Fondazione IRCCS San Gerardo dei Tintori in Monza.
The ADVENT study, registered on ClinicalTrials.gov as NCT06891781, is designed to compare the safety and effectiveness of adaptive and conventional deep brain stimulation delivered by Newronika's αDBS® system. This multicenter, randomized, double-blind crossover study is expected to enroll 104 adults with idiopathic Parkinson's disease who have been referred for bilateral deep brain stimulation of the subthalamic nucleus.
Rossi emphasized the significance of the study, which is designed to generate rigorous evidence by comparing adaptive and conventional stimulation in the same participants.
The ADVENT study uses a crossover design, meaning each participant will experience both conventional and adaptive modes of stimulation in a randomly assigned order. This approach ensures that the outcomes can be compared more accurately, as the participants serve as their own control group. The study is expected to involve up to 18 specialist clinical sites across the United States and the European Union.
Prof. Giorgio Carrabba, Principal Investigator for ADVENT at Fondazione IRCCS San Gerardo dei Tintori, highlighted the importance of the study for the clinical care of people with Parkinson's disease.
The αDBS® system, built on more than 20 years of advanced research and development, is designed to continuously sense, analyze, adapt to, and learn from brain signals. This adaptive technology is intended to provide more precise and personalized treatment for patients with Parkinson's disease, potentially improving their quality of life.
The study is expected to enroll 104 adults with idiopathic Parkinson's disease who have been referred for bilateral deep brain stimulation of the subthalamic nucleus. The participants will undergo both conventional and adaptive stimulation modes, with the outcomes assessed in a blinded manner to ensure unbiased results.
Newronika received FDA approval of an Investigational Device Exemption, allowing the company to initiate the ADVENT pivotal study. The study is intended to support a future Premarket Approval application for Newronika's DBS system in the United States. Enrollment is currently underway at participating study sites in Italy and is expected to soon begin in the United States.
The ADVENT study is part of Newronika's broader mission to develop advanced DBS technologies that can better address the complex needs of patients with Parkinson's disease. The company's αDBS® system represents a significant advancement in the field, offering the potential for more effective and personalized treatment options.