Pivotal trial of adaptive deep brain stimulation device hits key milestone
Newronika's AlphaDBS system implanted in first Parkinson's study patient
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The first Parkinson’s disease patient has been implanted with Newronika‘s adaptive AlphaDBS, an innovative deep brain stimulation (DBS) system, as part of a pivotal clinical trial underway in Italy.
The ADVENT study (NCT06891781) will compare the adaptive AlphaDBS system with conventional DBS in people with Parkinson’s. The trial is expected to enroll 104 adults with idiopathic (unknown cause) Parkinson’s who have been referred for DBS on both sides of the subthalamic nucleus, a brain region involved in movement.
Enrollment is underway in Italy and is expected to begin soon in the U.S., with additional European centers also planned. The trial is intended to generate evidence to support a future application for U.S. approval.
“This study is designed to generate rigorous evidence by comparing adaptive and conventional stimulation in the same participants. We are grateful to the participant[s], the clinical team, and all the investigators contributing to this international study,” Lorenzo Rossi, co-founder and CEO of Newronika, said in a press release.
AlphaDBS designed to continuously sense and analyze brain signals
Parkinson’s is a progressive neurological disorder marked by motor symptoms including tremor, muscle stiffness, and bradykinesia, or slowed movement.
DBS is an established surgical treatment for some people whose symptoms are not adequately controlled with medication. It involves implanting electrodes in specific brain regions and connecting them to a pulse-generating device that delivers electrical stimulation to alter abnormal brain activity.
Conventional DBS delivers stimulation using settings programmed by a clinician, which generally remain constant until manually changed. Adaptive DBS, by contrast, monitors brain activity and automatically adjusts stimulation within clinician-set limits as a person’s needs change.
AlphaDBS is designed to continuously sense and analyze brain signals and adjust electrical stimulation in response, creating a closed-loop system.
The technology has been in clinical development for several years. In 2021, the first person with Parkinson’s was implanted with AlphaDBS in a clinical study (NCT04681534) designed to assess its safety, tolerability, and potential effectiveness. The study compared adaptive stimulation with conventional stimulation during short hospital and at-home treatment periods.
Study intended to support application for US approval
In February 2025, Newronika raised € 13.6 million (around $15.2 million) to advance AlphaDBS after the U.S. Food and Drug Administration granted an investigational device exemption, allowing the system to be studied in the U.S. The company said at the time that the funding would help support pivotal clinical testing.
The following month, AlphaDBS received CE Mark approval in Europe for conventional and adaptive DBS in eligible people with Parkinson’s. The system remains investigational and is not FDA cleared or approved in the U.S.
Up to 18 specialist centers in the U.S. and European Union are expected to participate in the ADVENT study. Participants will receive conventional and adaptive DBS in a randomly assigned order. Neither patients nor the clinicians assessing their outcomes will know which mode is active during the comparison periods, allowing each participant to serve as their own comparison.
The design builds on AlphaDBS’ earlier, smaller studies and is intended to determine how the adaptive approach compares with conventional DBS in a larger group under controlled conditions.
The company said ADVENT is intended to support a future premarket approval application, the regulatory pathway it would use to seek FDA approval to market the system in U.S.
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