Multicenter Study on Tension-Type Headache Underway
A large clinical multicenter study on biofeedback and tension-type headache is currently underway at several Norwegian hospitals. The study, named BioTenCer, uses sensors and a mobile app provided by Cenli / Nordic Brain Tech as the technical solution for the biofeedback intervention. We are proud that our equipment is being used in a research project of this scale and quality, and that further clinical research is being conducted on biofeedback as a treatment approach within neurology.
A large multicenter study
BioTenCer is a planned multicenter study including approximately 300 patients, conducted over a period of three years. The study investigates digital, home-based, and therapist-independent biofeedback as a preventive treatment for patients with frequent and chronic tension-type headache.
The study is sponsored by Helse Nord-Trøndelag (HNT) and coordinated from Namsos Hospital, which is also one of the participating study sites.
The study has now started, and participating sites are being onboarded gradually. The following hospitals are participating or planned to be included:
- Namsos Hospital (Helse Nord-Trøndelag, HNT)
- St. Olavs Hospital, Trondheim
- University Hospital of North Norway (UNN), Tromsø
- Akershus University Hospital (Ahus), Lørenskog
- Haukeland University Hospital (HUS), Bergen
This makes BioTenCer one of the larger Norwegian clinical studies on biofeedback in this field, building on experience from the previously completed BioCer study on biofeedback for episodic migraine.
About the BioTenCer study
BioTenCer is a randomized, wait-list controlled, multicenter clinical study designed to assess the safety and efficacy of a home-based, app-based, and therapist-independent biofeedback treatment for patients with frequent and chronic tension-type headache.
In the study, participants perform biofeedback sessions at home using sensors and a smartphone app. The treatment is therapist-independent and carried out by the patient without direct involvement from healthcare personnel.
Approximately 300 adult participants are randomized to either active treatment or a wait-list control group. The treatment group performs daily 10-minute biofeedback sessions over a 12-week period. The study uses digital headache diaries and standardized endpoints to evaluate changes in headache burden over time.
PhD project and international scientific presentation
The BioTenCer study is part of a PhD project led by Kristina Devik, MD, consultant neurologist and PhD candidate at Namsos Hospital, Helse Nord-Trøndelag (HNT).
The study protocol was presented internationally by Kristina Devik at the European Headache Conference (EHC) 2025 in Lisbon, Portugal, in December. The presentation contributed to sharing the study design and methodology with the international headache and neurology research community.
The PhD project contributes to building more systematic knowledge on how home-based, therapist-independent biofeedback can be used in clinical practice for patients with tension-type headache.
Important research in a growing field
Biofeedback and regulation of the autonomic nervous system is a rapidly evolving field, where there is still a need for larger, well-designed clinical studies. That this type of research is now being conducted as a multicenter study within the Norwegian specialist healthcare system, and presented internationally, is both important and encouraging.
At Cenli and Nordic Brain Tech, we are highly motivated to see our technology used in independent clinical research and evaluated in medical practice. We follow the study with great interest and look forward to learning more as the project progresses.
Note: Cenli / Nordic Brain Tech is a supplier of equipment and software to the BioTenCer study, but is not the study sponsor and has no role in the study design, conduct, or reporting of results.
The study is registered on ClinicalTrials.gov (NCT07136740).
Official title: Biofeedback as Preventive Treatment in Tension Type Headache
More information about the study and participation is available on the Helse Nord-Trøndelag website:
https://www.hnt.no/kliniske-studier/hjemmebasert-biofeedback-som-forebyggende-behandling-av-spenningshodepine/