Clinical Trial

BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache

Study acronym: BioTenCer
Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this study is to test a therapist-independent home-based smartphone app-based biofeedback treatment in adults with tension type headache. The aim of the study is to assess the safety and performance of the Cerebri-TTH biofeedback device as a preventive treatment in adults with frequent and chronic tension type headache. The primary endpoint of the study is the change in the mean Area-Under-the-headache-Curve (AUC) from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the placebo group.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-21.
Status change: Not Yet Recruiting → Recruiting 2026-07-17
Trial Details
NCT Number NCT07136740
Lead Sponsor Helse Nord-Trøndelag HF
Collaborators: St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus, Haukeland University Hospital
Conditions Tension Type Headache
Enrollment 300 participants
Start Date 2025-10-17
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-21