The study results have been received by the startup, and a preliminary analysis is available upon request under NDA. The full results are expected to be published within the next few months.
Deep brain stimulation (DBS) is an established therapeutic option for selected patients with Parkinson’s disease who experience motor fluctuations despite optimal medical treatment.
In this context, a French multicenter clinical study, known as PARKEO2, is evaluating a new approach to targeting the subthalamic nucleus (STN) for DBS.
The study compares two procedures: on the one hand, an “Asleep” procedure performed under general anesthesia, without intraoperative electrophysiological microelectrode recordings, using the probabilistic targeting approach developed with supervised metamodels of Rebrain technology; and on the other hand, the standard procedure incorporating intraoperative microelectrode recordings (MER).
A Study Conducted Across Eight French Centers
The study, which began in November 2021, is sponsored by Bordeaux University Hospital (CHU de Bordeaux) and involves eight French hospitals: Amiens, Bordeaux, Lyon, Marseille, Nice, Rouen, Strasbourg, and Toulouse. The principal investigators are Dr. Julien Engelhardt, Professor Emmanuel Cuny, and Dr. Antoine Benard.
A total of 128 adult patients with idiopathic Parkinson’s disease, aged 38 to 71 years and experiencing motor fluctuations despite optimal medical treatment, have been enrolled in the study.
A Key Question: Can Targeting Be Simplified Without Compromising Clinical Benefit?
The primary objective of PARKEO2 is to compare the improvement in motor function achieved one year after subthalamic nucleus DBS using the two different approaches.
The primary endpoint is based on the change in the UPDRS Part III motor score at one year.
The study also assesses several secondary endpoints to evaluate different aspects of the two procedures, including stereotactic accuracy, procedure duration, radiation exposure, pneumocephalus, length of hospital stay, reduction in L-dopa dosage, cognitive function, surgical complications, as well as the overall cost of the procedure and its cost-effectiveness.
Together, these parameters are intended to assess not only clinical efficacy, but also safety, surgical conditions, and the health-economic impact of this approach.
An Important Step for Innovation in Functional Neurosurgery
For Rebrain, this study represents an important step in the clinical validation of its targeting approach in functional neurosurgery.
Beyond technological performance, the key question is whether a probabilistic targeting strategy can enable an “Asleep” DBS procedure without microelectrode recordings, while maintaining clinical outcomes comparable to those achieved with the standard procedure.
These results will be presented in detail at the 2026 World Society for Stereotactic and Functional Neurosurgery Congress in Marseille on October 1, 2026, during an international expert symposium featuring leading neurosurgeons from the U.S. and Europe.
To be followed: the full PARKEO2 results and their analysis by the investigators.
PARKEO2 Study — ClinicalTrials.gov Identifier: NCT04884412
Find us at WSSFN 26
Rebrain is located in the exhibition foyer, on the right-hand side after the registration area, next to the coffee area. The Lunch Symposium takes place in Room 76: follow the congress signage from the main entrance.
Find us within WSSFN 26 (Floor plan – How to get to us)
