E115549 (CEREBRI) Developing cost-effective biofeedback treatment for patients suffering from migraines

Migraine is a network disease in the brain that affects 14% of the population. People with migraines often have reduced quality of life and a lack of treatment options. Medications are often associated with negative side-effects, and there is a growing need for non-pharmacological treatment with a documented effect. At the Norwegian University of Science and Technology (NTNU), researchers have been working since 2015 with a preventive biofeedback treatment for headaches and migraines. The treatment, CEREBRI, consists of two wireless sensors and a treatment program in a mobile application. CEREBRI has the potential to reduce the number of days with migraines by 50%, and is a treatment that should be easy to use, available and affordable. Development of the CEREBRI technology and implementation of a clinical study is done in a Eurostars project through Eureka, in collaboration with two Norwegian partners (NTNU and Nordic Brain Tech AS), and two internationals from Sweden (i3tex AB) and Estonia (Thorgate Digital OÜ ). CEREBRI is developed as a medical device with strict regulatory requirements for documentation and risk management. The project started in August 2021 with a duration of two years. The aim of the project is to validate CEREBRI as a cost-effective treatment for migraines.

14.7% of the population is affected by migraine headaches: the most common neurological disorder costing EU €50 billion annually. There is a pressing need for treatments without side-effects, that are cheaper and more accessible. By introducing a novel digital health treatment, CEREBRI will fill this demand and improve people's quality of life. CEREBRI aims to further develop and validate a cost-effective biofeedback treatment for patients suffering from migraines. It’s a remote medical device that enables virtual care and home-treatment, using a smartphone and biosensors, that can prevent migraine attacks by 50%, and help patients manage their condition with self-assessments. We will complete software and hardware optimisation, prototype assembly for a clinical validation study and perform the clinical validation study.