If you are a device manufacturer dealing with the limitation of fixed-parameter stimulation—where patients spend 20-30% of the day with symptoms—this project developed AlphaDBS, a closed-loop system that automatically adjusts intensity based on brain signals.
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What needed solving
Current DBS systems use fixed parameters regardless of real-time brain activity, leaving patients with symptoms for 20-30% of the day and requiring frequent, costly neurologist visits.
What was built
An adaptive DBS system (AlphaDBS) with a closed-loop algorithm and a cloud-based remote monitoring database for neurologists.
Who needs this
Who can put this to work
If you are a health-tech company dealing with the need for frequent in-person neurology visits, this project developed a cloud-based database feature that allows doctors to track brain signals and system status remotely.
If you are a clinic dealing with the high operational burden of managing conventional DBS therapy, this project developed a system that uses beta-band power to compute new stimulation values every second, reducing the need for manual tuning.
Quick answers
What is the cost or pricing of the AlphaDBS system?
Based on available project data, the specific commercial price or cost per unit is not disclosed; however, the project received an EU contribution of EUR 2,499,999 for development.
Is the technology ready for industrial scale production?
Yes, the project report states the device was upgraded in electronics and software to make it more suitable for manufacturing.
What is the IP or licensing status of the adaptive algorithm?
Based on available project data, the IP is held by the coordinator, Newronika SPA, who developed the adaptive algorithm that computes stimulation values every second.
What regulatory hurdles have been cleared?
The project completed a double-blind crossover study providing the clinical data necessary to obtain CE marking under the MDR for both conventional and adaptive modes.
What is the timeline for clinical validation?
The project ran from 2023-03-01 to 2025-02-28, during which the European study was completed and approvals for the international ADVENT study were obtained.
Who built it
The project is led by a single Italian SME, Newronika SPA, which acted as the sole partner. This 100% industry-led structure indicates a strong focus on commercialization and direct product development rather than academic research, as evidenced by the focus on CE marking and manufacturing suitability.
Contact Newronika SPA in Italy regarding AlphaDBS licensing or partnerships.
Talk to the team behind this work.
Contact us to explore integration of adaptive neuromodulation into your product portfolio.