BioCer randomized controlled trial published in Cephalalgia
The results of the BioCer randomized controlled trial have been published in Cephalalgia, the journal of the International Headache Society.
Link to publication: https://journals.sagepub.com/doi/10.1177/03331024261480724
The BioCer trial evaluated a fully self-administered, smartphone-based biofeedback treatment for adults with episodic migraine, built on app and sensor technology developed by Nordic Brain Tech.
Across 279 participants at four Norwegian hospitals, twelve weeks of app-based biofeedback produced a significant reduction in monthly migraine days compared with the control group. To our knowledge, this is the first fully self-administered mHealth biofeedback intervention to demonstrate such a reduction in a randomized controlled trial.
Key results
- 44 percent of participants in the treatment group achieved at least a 30 percent reduction in monthly migraine days, compared with 30 percent in the control group.
- Participants also reported lower migraine intensity, reduced use of acute analgesics, and improved migraine-specific quality of life.
- The treatment demonstrated a favourable safety profile.
- The intervention required no therapist-led training and no clinic visits at any stage.
Why the result matters
Biofeedback has been recommended in headache treatment guidelines for years on the strength of its evidence base. In practice, very few patients have ever received it. Traditional biofeedback requires a trained therapist, stationary clinic equipment, and repeated in-person sessions, which places a hard ceiling on how many patients any health system can treat.
BioCer addresses that constraint directly. The intervention was delivered entirely through wireless sensors and a smartphone application, with no clinician time required for training or delivery. This is what makes the result commercially as well as clinically significant: a treatment whose delivery cost does not rise with each additional patient can be offered at a scale that clinic-based biofeedback never could.
Migraine affects more than one billion people worldwide and remains among the leading causes of years lived with disability. A substantial share of patients discontinue preventive medication because of side effects or insufficient effect. A non-pharmacological preventive option with a favourable safety profile, delivered at home, addresses a gap that current treatment pathways leave open.
Path to market
Nordic Brain Tech's next step is to bring the therapy to patients as a certified medical device. Further detail on launch markets and commercial partnerships will follow.
Cerebri is the name under which the device was evaluated in the BioCer trial. The commercial product Cenli (available today as a wellness device) will be brought to market as a certified medical device under the EU Medical Device Regulation in 2027.
Read the publication: https://journals.sagepub.com/doi/10.1177/03331024261480724
Read our previous news article about the trial results: