Home-based biofeedback device for migraine prevention in development

Cerebri has been under development since 2015 with the aim of bringing to market a research-based intervention for preventive migraine treatment. This innovative approach utilizes remote biofeedback techniques to address migraine symptoms and enhance patient care.


Finger sensor & neck sensor

Randomized controlled trial in progress
Patients being tested
More than 300
Non-pharmacological medical device class IIa
Developed in
Patent pending

The concept

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.

The innovation

How it works

Cerebri utilizes two wireless sensors and a smartphone application to help patients receive biofeedback therapy. The therapy is a self-assisted solution to be used at home for 10 minutes per day for at least 12 weeks. The app is available on both platforms, Android and iPhone, and offers a dark mode option for increased accessibility. The app guides you through the session, and gives instructions on how to breathe and how to reach a biofeedback goal.

Before starting a session with Cerebri, you should find a comfortable and quiet place to sit. You connect the sensors to your mobile phone and follow simple instructions in the app. One sensor is attached to the fingertip to measure temperature and heart rate variability, and the second sensor is attached to the neck to measure tension.

Now keep still, follow a breathing pacer with your breath, watch the measurements and relax. When you complete a biofeedback session after 10 minutes, you remove the sensors and put them away for the next session. That's it!

Short version

  • Turn on and attach the sensors to your body
  • Start a session to connect sensors to the Cerebri application
  • Pay attention to the instructions
  • Breathe and relax
  • Wait until tomorrow and repeat

The science

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.

List of publications

Scientific publications

Stubberud, Anker et al. Biofeedback as Prophylaxis for Pediatric Migraine: A Meta-analysis. Pediatrics vol. 138,2 (2016): e20160675. doi:10.1542/peds.2016-0675

Stubberud A, Omland P, Tronvik E, Olsen A, Sand T, Linde M. Wireless Surface Electromyography and Skin Temperature Sensors for Biofeedback Treatment of Headache: Validation Study with Stationary Control Equipment. JMIR Biomed Eng 2018;3(1):e1. doi:10.2196/biomedeng.9062

Stubberud, A., Tronvik, E., Olsen, A., Gravdahl, G. and Linde, M. (2020), Biofeedback Treatment App for Pediatric Migraine: Development and Usability Study. Headache: The Journal of Head and Face Pain, 60: 889-901. doi.org/10.1111/head.13772

Stubberud A, Linde M, Brenner E, et al. Self-administered biofeedback treatment app for pediatric migraine: A randomized pilot study. Brain Behav. 2021; 11:e01974. doi: 10.1002/brb3.1974

Ingvaldsen S, Tronvik E, Brenner E, Winnberg I, Olsen A, Gravdahl G, Stubberud A. A Biofeedback App for Migraine: Development and Usability Study. JMIR Form Res 2021;5(7):e23229. doi: 10.2196/23229

Stubberud A, Ingvaldsen SH, Brenner E, et al. Forecasting migraine with machine learning based on mobile phone diary and wearable data. Cephalalgia. 2023;43(5). doi: 10.1177/03331024231169244

Grant received for Cerebri development