Cerebri

Cerebri is a preventive intervention for migraine treatment, building on years of clinical research

Cerebri is a preventive migraine therapy based on biofeedback. Biofeedback involves measuring bodily parameters, which individuals observe and then learn to influence as part of relaxation therapy. It helps patients monitor and control their stress level in the body.

By using biofeedback, research has already shown that it has a preventive effect on migraines. However, biofeedback is expensive in its traditional format where stationary equipment and a trained therapist is needed. Although biofeedback is already recommended in international guidelines, its availability is limited. Cerebri solves this problem by bringing biofeedback therapy home to patients, making it more affordable and accessible. You can read more about what biofeedback is in our News section.

Clinical validation

Cerebri is developed as a class IIa medical device (according to the EU Medical Device Regulation - MDR, and ISO 13485), and is built on years of research from the Norwegian University of Science and Technology (NTNU). It all started in 2015, when a systematic review with meta-analysis showed that biofeedback, as a prophylactic treatment for migraine in adolescents, is effective in a traditional clinical setting. Continuing into 2017, wireless sensors measuring peripheral skin temperature and neck sEMG voltage connected via Bluetooth to a smartphone app were compared to traditional neurophysiological “golden-standard” measuring equipment. The project proceeded in 2018 with a usability and development study to assess the usability, feasibility, and safety of the concept. This study also functioned as an experimental proof-of-concept study.

In 2019, a pilot efficacy study on 23 adolescents was performed to investigate the effect size, safety, and tolerability of a therapist-independent biofeedback treatment app among adolescent with migraine. In 2020, a development and usability study was performed to evaluate and improve the feasibility and usability of an mHealth biofeedback treatment app for adults with migraine. A prediction algorithm of migraine was also developed.

In 2022, a pilot clinical trial was performed to test the feasibility, usability, safety, efficacy, and tolerability of Cerebri for adults with episodic migraine (publication in review). In 2023, a randomized controlled trial started to test the effectiveness and safety Cerebri, for migraines in adults. Read more about the trial here.

The device is in the final stages of validation. Claims are to be considered final after the completion of the technical documentation and review by the Notified Body.