First patient implanted in Newronika's pivotal trial of adaptive deep brain stimulation
The ADVENT study will compare adaptive and conventional DBS in 104 people with Parkinson's disease across the US and Europe.
Italian company Newronika has announced the first implant in ADVENT, a pivotal clinical trial of its adaptive deep brain stimulation (aDBS) system for Parkinson’s disease. The procedure took place on September 21 at Fondazione IRCCS San Gerardo dei Tintori hospital in Monza, Italy.
The study
- Who: 104 adults with Parkinson’s disease that responds to levodopa but isn’t well controlled by medication.
- Where: up to 18 specialist centers in the United States and European Union.
- Design: randomized, double-blind crossover. Each participant experiences both adaptive and conventional stimulation, and neither they nor their assessors know which is active.
- Status: the FDA approved the study under an investigational device exemption, and the device is already CE-marked in Europe.
Adaptive vs. conventional DBS
Conventional deep brain stimulation delivers fixed settings around the clock. Adaptive DBS reads brain signals, especially local field potentials linked to symptoms, and adjusts stimulation in real time, a closed-loop approach.
Why it matters
A pivotal trial is the large study regulators rely on to decide approval. Strong results would add a second major adaptive DBS option, after Medtronic’s, and support the shift toward brain implants that sense and respond.
Learn more: Deep brain stimulation · Clinical trial pathway · Newronika in the Directory