Newronika implants first participant in Parkinson's adaptive stimulation study

Medical technology firm Newronika announced it has implanted the first participant in its pivotal ADVENT study, which investigates adaptive deep brain stimulation (aDBS) for Parkinson's disease. The procedure occurred on September 21st at the Hospital Fondazione IRCCS San Gerardo dei Tintori in Monza, Italy.

The ADVENT study is a multicenter, randomized, double-blind crossover trial comparing the safety and effectiveness of Newronika's αDBS® system in adaptive mode versus conventional stimulation. The study aims to enroll 104 adults with Parkinson's disease across up to 18 clinical sites in the United States and the European Union.

"This study is designed to generate rigorous evidence by comparing adaptive and conventional stimulation in the same participants," said Lorenzo Rossi, Co-Founder and CEO of Newronika. The company expects the study to support its future Premarket Approval application for its DBS system in the United States.

Professor Giorgio Carrabba, Principal Investigator for ADVENT at Fondazione IRCCS San Gerardo dei Tintori, noted the implantation as a significant milestone for the study and the hospital's neuromodulation program. The αDBS® system is already CE-marked in the European Economic Area for Parkinson's disease symptom management.

In the United States, the device is currently investigational. Deep brain stimulation is a treatment option for Parkinson's patients whose symptoms are not adequately controlled by medication. Conventional DBS uses constant settings, while adaptive DBS adjusts stimulation dynamically based on recorded brain activity.