Press Release: Positive Clinical Trial Results for Cerebri for Migraine Prevention
Oslo, Norway – May 30, 2025 – Nordic Brain Tech, a leader in neurotechnology and digital therapeutics, today announced positive results from a randomized controlled trial evaluating Cerebri, its novel app- and sensor-based therapy for the preventive treatment of migraine.
The randomized, controlled, multicenter trial BioCer enrolled 279 participants across four leading university hospitals in Norway. The primary endpoint was met, demonstrating a statistically significant reduction in monthly migraine days compared to a waitlist control group. Key secondary endpoints — including patient-reported quality of life, acute medication use, and responder rate — also reached statistical significance. The therapy was safe, well tolerated, and highly engaging, with strong adherence across the treatment period.
“The results are very promising. This is a rigorous clinical study showing that this non-pharmacological treatment leads to a reduction in migraine days. The fact that the therapy is delivered at home without guidance from healthcare professionals represents something of a revolution in migraine care,” says Principal Investigator Dr. Tore Wergeland Meisingset at St. Olavs Hospital.
Compared to current treatment options, Cerebri offers a side-effect-free, home-based alternative that aligns with patient preferences for non-drug therapies. Cerebri builds on biofeedback, which has long been a recognized and effective approach in headache treatment, offering patients a way to manage symptoms by learning to control physiological processes such as muscle tension and skin temperature. However, traditional biofeedback therapy has typically required repeated in-office visits, limiting accessibility and convenience for many patients.
«The BioCer study is the first clinical trial demonstrating effect of an mHealth/app based biofeedback treatment for migraine. BioCer is a high-quality randomized controlled trial demonstrating effect of app-based biofeedback; indeed it is one of the largest published trials demonstrating an effect of biofeedback in general», Dr. Anker Stubberud MD, PhD in Neurology, the Norwegian University of Science and Technology
“This is a major step forward in non-pharmacological migraine management. We now have robust evidence that patients can benefit from clinically effective biofeedback therapy in their own homes, on their own schedule. The trial’s findings support the integration of home-based biofeedback as a viable and effective treatment option for migraine sufferers seeking alternatives to medication, particularly those sensitive to side effects or looking to reduce drug dependency.
The BioCer clinical trial has demonstrated that a novel home-based biofeedback system can significantly reduce the number of migraine days—achieving therapeutic effects comparable to many prophylactic drug treatments currently in use.” – Dr. Erling Tronvik, Professor at the Norwegian University of Science and Technology (NTNU) and Senior Neurologist at St. Olavs Hospital - Trondheim University Hospital
Key Clinical Highlights
- Significant reduction in Monthly Migraine Days over 12 weeks, with mean difference: -0.9 days (95% CI -1.5 to -0.3, p = 0.002)
- Reduced Migraine Intensity: the treatment group achieved reduced intensity of migraine attacks (p = 0.006)
- Responder Rate: More patients achieved ≥30% reduction in migraine days (p = 0.033)
- Improved Quality of Life: Statistically significant gains in MSQ v2.1 scores (p = 0.020)
- Reduced Medication Use: Fewer days with acute medication reported (p = 0.030)
Cerebri is a safe and effective preventive treatment for adults with episodic migraine. Cerebri was well tolerated with no serious device-related events.
The clinical trial results were first reported at the 18th European Headache Congress 4-7 December 2024 in Rotterdam (NL).
About Cerebri
Cerebri is a digital therapeutic that combines a mobile application with two wireless biosensors to deliver 10-minute, self-guided biofeedback sessions at home. The system tracks muscle tension (EMG), skin temperature, and heart rate variability (HRV). These are three physiological signals associated with migraine onset, and provides real-time visual feedback to help users regulate their stress response.
This approach allows patients to train autonomic nervous system balance through a guided biofeedback session — all without the need for medications or in-person clinical visits.
Market Potential & Next Steps
Migraine is one of the world’s most disabling neurological disorders, affecting over 1 billion people globally. Existing treatments often present side effects or require clinic-based interventions. Cerebri is uniquely positioned to meet the demand for an effective, home-based solution.
With this successful trial completed, Nordic Brain Tech is preparing for CE marking under MDR in Europe and intends to pursue regulatory engagement with U.S. authorities, while actively exploring commercial partnerships and distribution channels worldwide.
“We’re redefining migraine prevention,” said Heuch. “Our goal is to empower millions living with migraine by putting clinically validated neurotechnology in their hands.”
About the clinical trial
The BioCer clinical trial was conducted by NorHead – Norwegian Centre for Headache Research and Norwegian University of Science and Technology, at four hospitals in Norway: St. Olavs University Hospital, Akershus University Hospital, Haukeland University Hospital, University Hospital of North Norway. Results from the trial were first presented at The European Headache Congress in Rotterdam in December 2024.
Trial information
- Trial registration: NCT05616741, 2022-11-15 https://clinicaltrials.gov/study/NCT05616741
- EUDAMED: CIV-NO-22-08-040446
- REK (Regional Committees for Medical and Health Research Ethics): 502734 Date of approval 2022-10-14
- Protocol publication with statistical analysis plan: Poole AC, Stubberud A, Simpson M et al. Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial – the study protocol [version 1; peer review: 1 approved]. F1000Research 2024, 13:775 (https://doi.org/10.12688/f1000research.149807.1)
- Grant information: The clinical trial is funded by public research grants from the Eurostars project (E! 115549 – CEREBRI) and the Oslo Regional Research Fund. The Eurostars Program is a joint initiative of EUREKA and the European Community. The project partners where the Norwegian University of Science and Technology, Together Tech and Thorgate Digital.
About Nordic Brain Tech
Nordic Brain Tech is a Norwegian digital health company developing non-invasive neurotechnology to treat neurological and pain disorders. Founded by clinicians and engineers, the company specializes in integrating wearable biosensing, behavioral science, and digital therapeutics to create accessible, scalable treatments grounded in rigorous clinical validation