PORTEFEUILLE

Stroke, the leading cause of disability globally, results in neural circuit damage that impairs everyday movements. Current physical therapy approaches do not directly address this core issue and are limited to short clinic stays. Advanced tools for neural rehabilitation at home are lacking, despite over 100 million people in need. SmartVNS, developed by ETH researchers Paulius Viskaitis and Dane Donegan, addresses these gaps by integrating cutting-edge sensors, AI, and neural modulation into a user-friendly package similar to a smartphone. It includes a wearable earpiece and motion tracker bracelet that wirelessly transmit real-time movement data. The earpiece stimulates the auricular Vagus nerve (aVNS) with electrical impulses, promoting neural circuit rewiring and brain function restoration. Studies have shown that early use of such brain stimulation, combined with rehabilitation, can reduce damage and accelerate recovery. SmartVNS achieves this in an automated manner, enabling patients to use it independently at home during daily activities. The system's analysis software collects movement data for diagnostics, treatment guidance, and therapy adherence. With its intelligent therapy and affordable design, SmartVNS can provide cutting-edge neuro-rehabilitation to stroke patients from vulnerable, remote, and low-income backgrounds. The project aims to validate SmartVNS in partner clinics, demonstrate feasibility and efficacy, seek regulatory approval, and ultimately market it as a certified medical device. Successful realization of SmartVNS would address existing challenges in stroke rehabilitation and potentially benefit individuals with traumatic brain injury, spinal cord injury, and Parkinson's disease.

The long-term aims of the SmartVNS are to address the gap in the accessibility of neural rehabilitation tools for stroke patients. Up to now, SmartVNS project has successfully developed and lab-validated prototypes as well as obtained necessary agreements for it’s next big milestone - clinical feasibility validation. If successful, this trial will serve as a crucial step towards technical as well as clinical validation. Learnings from the trial will drive future activities in product development, clinical efficacy trials and eventual regulatory market approval. The InnoBooster provides invaluable and timely support to accelerate the SmartVNS and development and market entry the SmartVNS system.