Periodic Reporting for period 2 - NEUROSENSE (NEUROendocrine SENSor for Sudden Unexpected Death in Epilepsy (SUDEP) prediction and prevention)
Periodo di rendicontazione: 2023-06-01 al 2024-11-30
Imagine the helplessness of being told your child, recently diagnosed with epilepsy, is at a high risk of dying suddenly, without warning and without a known cause, often in their sleep. The doctors inform you this phenomenon threatening your child's life is called Sudden Unexpected Death in Epilepsy (SUDEP), but that there is very little you can do to prevent it. Imagine the disruption to your life, as you spend hours riddled with constant worry and care-worn sleepless nights. And despite taking extensive measures to monitor your child and their epilepsy, they tragically still succumb to a silent death that you were powerless to predict or prevent. For many families living with epilepsy, this is their reality. 65 million people with epilepsy are at risk of SUDEP. However, SUDEP cannot be predicted nor prevented. The NEUROSENSE project aims to develop the first SUDEP Medical Device (SMD) prototype supported by artificial intelligence (AI) capable of anticipating life-threatening seizures and trigger an automatic emergency drug administration to prevent SUDEP.
Achieving such disruptive technology requires a close unconventional collaboration model between actors in different scientific domains. The NEUROSENSE Consortium has a deep interdisciplinary nature bridging different domains of science and technology: animal modelling and neurobiology (Centre National de la Recherche Scientifique – CNRS), clinical neurology (Filadelfia Epilepsy Hospital – Dianalund and Centre Hospitalier Universitaire Vaudois - CHUV), analytical mass spectrometry (Instituto de Investigação e Inovação em Saúde - i3S), mathematical modelling, e-health software development, product design in health sector, medical device implementation, GPDR/HIPAA knowledge (Kinetikos Health), biotechnology, product design, marketing and IP (Biostrike), biosensors and medical electronics (Karolinska Institutet). This synergy of expertise will make it possible to present a breakthrough solution for a major societal challenge helping the EU to attain leadership in the specific domain of SUDEP. Based on the new SMD technology, we will build a diverse portfolio of future projects that will result in long-term benefits for people with epilepsy, their families, caregivers, society and the economy.
Achieving such disruptive technology requires a close unconventional collaboration model between actors in different scientific domains. The NEUROSENSE Consortium has a deep interdisciplinary nature bridging different domains of science and technology: animal modelling and neurobiology (Centre National de la Recherche Scientifique – CNRS), clinical neurology (Filadelfia Epilepsy Hospital – Dianalund and Centre Hospitalier Universitaire Vaudois - CHUV), analytical mass spectrometry (Instituto de Investigação e Inovação em Saúde - i3S), mathematical modelling, e-health software development, product design in health sector, medical device implementation, GPDR/HIPAA knowledge (Kinetikos Health), biotechnology, product design, marketing and IP (Biostrike), biosensors and medical electronics (Karolinska Institutet). This synergy of expertise will make it possible to present a breakthrough solution for a major societal challenge helping the EU to attain leadership in the specific domain of SUDEP. Based on the new SMD technology, we will build a diverse portfolio of future projects that will result in long-term benefits for people with epilepsy, their families, caregivers, society and the economy.
During the second reporting period, NEUROSENSE scientific and technical efforts were directed at continuing to develop the work performed in the previous reporting period. The main focus was to develop an ECoG-based seizure detection algorithm (as suggested during the 1st Project Review Meeting), apply the pre-clinical and clinical protocols that were refined during the 1st reporting period, analyse the samples collected from those experiments and continue with the development of the SUDEP Medical Device (SMD). These efforts have resulted in important breakthroughs that position the project closer to achieving the proof of concept that underlines it. Among these efforts, the Consortium has:
1- Completed the pre-clinical setup and applied the acute experimental protocols refined during the 1st reporting period. Samples were then collected and analysed through mass spectrometry. The results were also weekly analysed by the Consortium, which enabled the application of quick adjustments to the setup or to the planned experiments as needed.
2- Developed an ECoG-based seizure detection algorithm with 91% precision and 95% sensitivity. This development will allow the performance of critical chronic experiments in the pre-clinical setting. The algorithm is already being tested in that setting. This will bring us closer to achieving the proof of concept.
3- Development of Biomarker-Specific Sensors: The team successfully developed and optimized electrochemical sensors using molecularly imprinted polymers and aptamers for specific biomarker detection. These sensors showed reliable performance in analytical standards.
4- Integration of Sensor Regeneration Techniques: The Consortium implemented an innovative electrochemical switching approach for sensor surface regeneration, enhancing the device's reusability in physiological media without extensive washing.
5- Prototyping of Wearable Sensor Devices: The project advanced towards creating wearable devices by integrating custom-designed PCBs with printed electrodes. This included developing a user interface for wireless sensor readouts and demonstrating feasibility in real-time cortisol monitoring scenarios.
6- Improved and updated the Risk and Data Management Plans to meet new demands arising from the natural progression of the project.
7- Completed the approval of the clinical experimental protocols and began recruiting volunteers and collecting blood and saliva samples for mass spectrometry analyses.
8- One workshop directed at collecting end-user needs and preferences to be included in the final design of the medical device being developed in the scope of WP2 was completed. A second workshop is underway.
1- Completed the pre-clinical setup and applied the acute experimental protocols refined during the 1st reporting period. Samples were then collected and analysed through mass spectrometry. The results were also weekly analysed by the Consortium, which enabled the application of quick adjustments to the setup or to the planned experiments as needed.
2- Developed an ECoG-based seizure detection algorithm with 91% precision and 95% sensitivity. This development will allow the performance of critical chronic experiments in the pre-clinical setting. The algorithm is already being tested in that setting. This will bring us closer to achieving the proof of concept.
3- Development of Biomarker-Specific Sensors: The team successfully developed and optimized electrochemical sensors using molecularly imprinted polymers and aptamers for specific biomarker detection. These sensors showed reliable performance in analytical standards.
4- Integration of Sensor Regeneration Techniques: The Consortium implemented an innovative electrochemical switching approach for sensor surface regeneration, enhancing the device's reusability in physiological media without extensive washing.
5- Prototyping of Wearable Sensor Devices: The project advanced towards creating wearable devices by integrating custom-designed PCBs with printed electrodes. This included developing a user interface for wireless sensor readouts and demonstrating feasibility in real-time cortisol monitoring scenarios.
6- Improved and updated the Risk and Data Management Plans to meet new demands arising from the natural progression of the project.
7- Completed the approval of the clinical experimental protocols and began recruiting volunteers and collecting blood and saliva samples for mass spectrometry analyses.
8- One workshop directed at collecting end-user needs and preferences to be included in the final design of the medical device being developed in the scope of WP2 was completed. A second workshop is underway.