The procedure, performed on September 21, marks a critical step for the Milan-based medical technology firm. The ADVENT study, registered as NCT06891781, utilizes a double-blind crossover design to evaluate 104 adults diagnosed with idiopathic Parkinson’s disease. By requiring each participant to experience both adaptive and conventional stimulation modes in a randomized sequence, researchers intend to generate rigorous data on safety and efficacy for subthalamic nucleus stimulation.
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Newronika Begins Pivotal ADVENT Study with First Patient Implant
A patient at the Hospital Fondazione IRCCS San Gerardo dei Tintori in Monza has become the first to receive the αDBS® implant as part of Newronika’s international ADVENT study. This pivotal trial aims to determine if adaptive deep brain stimulation provides superior outcomes for Parkinson’s disease compared to conventional methods.
CEO Lorenzo Rossi stated that the trial is essential for the clinical development of their adaptive technology, which dynamically adjusts stimulation based on recorded brain activity. Prof. Giorgio Carrabba, the principal investigator at the Monza site, noted that the implantation reflects the multidisciplinary commitment to advancing surgical care for patients whose symptoms remain inadequately controlled by standard medication. The company plans to expand enrollment across 18 specialist clinical sites throughout the United States and the European Union, using the findings to support a future Premarket Approval application with the FDA.
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