Periodic Reporting for period 2 - TARA (Disrupting the Migraine continuum of care for resource constrained settings)
Reporting period: 2023-09-01 to 2024-08-31
Migraine is a common and disabling condition reported in approximately 12% of the population. In the Global Burden of Disease Study in 2019, migraine was found to be the third highest cause worldwide of years lived with disability. When we consider the Chronic migraine, defined as headache occurring on 15 or more days per month for more than three months, we find that it affects 1% to 2% of the global population. Treatments of migraine is usually based on pharmaceutical drugs, which have contra-indications and severe side effects and often remain ineffective in chronic migraine patients. Neurostimulation is a last treatment option, despite often being more effective than pharma treatments. This is mainly due to the surgical invasiveness of neurostimulators limiting the market to surgically trained physicians, which increases the risks and the costs.
Our vision at TARA is fundamentally based on disrupting the continuum of care and referral pathway by creating a more effective non-surgical solution that reduces cost and risk and therefore enables more physicians to treat more patients. The TARA consortium members are currently developing a novel platform for treating migraine, which will be particularly applicable in resource-restricted environments and will target underserved patients. In particular, the platform consists of 4 elements working together that are (i) an implantable electronic device with neural stimulation, (ii) an ergonomic, minimally invasive, injectable delivery system designed specifically to enable non-surgical physicians to deliver the implant to target anatomical locations, (iii) a wearable device which communicates with and delivers wireless power to the implant and (iv) a mobile app to control the implant.
Our vision at TARA is fundamentally based on disrupting the continuum of care and referral pathway by creating a more effective non-surgical solution that reduces cost and risk and therefore enables more physicians to treat more patients. The TARA consortium members are currently developing a novel platform for treating migraine, which will be particularly applicable in resource-restricted environments and will target underserved patients. In particular, the platform consists of 4 elements working together that are (i) an implantable electronic device with neural stimulation, (ii) an ergonomic, minimally invasive, injectable delivery system designed specifically to enable non-surgical physicians to deliver the implant to target anatomical locations, (iii) a wearable device which communicates with and delivers wireless power to the implant and (iv) a mobile app to control the implant.
The project has a duration of three years and the activity of the first two years has been focused on the development and characterization of the hardware and software of the platform. The main achievements of the research activity performed during the first two years of the project are:
-) Design, fabrication, testing and optimization of the innovative, ergonomic, minimally invasive, injectable delivery system;
-) Design and preliminary tests of the minimally invasive, electronic implant with high bandwidth bidirectional communications;
-) Design, fabrication, characterization and validation of the ASIC chip for neural stimulations;
-) Design, fabrication and testing of a new version of the ASIC chip for ultra-low power bio-potential/impedance and electrochemical measurements;
-) Launch on Apple Store and Google Market of the Mobile application for patients configured for multiple features and development of the Web portal for clinicians and system administrators;
-) Design of the Pre-clinical and Therapeutic Study Protocols to evaluate the safety and clinical utility of the proposed system;
-) Design and finalization of the Diagnostic Study Protocol to demonstrate the clinical use of combining the App and wearable in monitoring and managing patients with migraine.
-) Design, fabrication, testing and optimization of the innovative, ergonomic, minimally invasive, injectable delivery system;
-) Design and preliminary tests of the minimally invasive, electronic implant with high bandwidth bidirectional communications;
-) Design, fabrication, characterization and validation of the ASIC chip for neural stimulations;
-) Design, fabrication and testing of a new version of the ASIC chip for ultra-low power bio-potential/impedance and electrochemical measurements;
-) Launch on Apple Store and Google Market of the Mobile application for patients configured for multiple features and development of the Web portal for clinicians and system administrators;
-) Design of the Pre-clinical and Therapeutic Study Protocols to evaluate the safety and clinical utility of the proposed system;
-) Design and finalization of the Diagnostic Study Protocol to demonstrate the clinical use of combining the App and wearable in monitoring and managing patients with migraine.
The injectable delivery system designed and fabricated by the partner Capri Medical is the only minimally invasive device available in the market to inject hermetically sealed implants & leads. It is not the first minimally invasive device to market, there are existing first generation devices, but the proposed device is the only way to inject hermetically sealed implants & leads, a unique global capability. The proposed device is a fundamental invention, which enables a single-handed injection procedure, and it is an EPO patent granted in 2023 which is currently being nationalised in 13 countries around the world.
The developed mobile application has been launched in the Apple Store and Google Play Market with the name of OPORA App. The App is aimed to collect patient data via the connection to wearable devices, My Diary tool and Questionnaires filled out by the patient.
The ASICs for the neural stimulation and sensing includes many innovative architectures to satisfy the requirements of minimum power consumption and area occupation imposed by the integration into a battery-less implantable device.
The developed mobile application has been launched in the Apple Store and Google Play Market with the name of OPORA App. The App is aimed to collect patient data via the connection to wearable devices, My Diary tool and Questionnaires filled out by the patient.
The ASICs for the neural stimulation and sensing includes many innovative architectures to satisfy the requirements of minimum power consumption and area occupation imposed by the integration into a battery-less implantable device.