Evaluating the Cerebri-TTH Biofeedback Device as a Preventive Treatment for Frequent and Chronic Tension Type Headache in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a home-based smartphone app biofeedback treatment called Cerebri-TTH for adults with frequent and chronic tension type headache TTH. The study involves 300 adults diagnosed with TTH to compare this biofeedback treatment against a wait-list control group. The main goal is to assess changes in headache intensity and duration measured by the Area-Under-the-headache-Curve AUC from baseline to the end of treatment. Participants in the treatment group use the Cerebri-TTH device daily for 10-minute biofeedback sessions over 12 weeks. This device includes two sensors one placed on the trapezius muscle to measure muscle tension and another on the index finger to track heart rate, heart rate variability, and skin temperature. The wait-list group does not receive treatment during the initial 12 weeks but completes daily headache diaries and is offered treatment in a later extension phase. Both groups maintain daily diary entries throughout the study. Participants undergo a 4-week baseline period of daily headache diaries before randomization. After the treatment or wait-list period, follow-up includes telephone contacts and final visits. An optional 12-week extension allows continued diary recording for both groups. The study measures headache frequency, intensity, duration, medication use, anxiety, depression symptoms, and device safety over up to 38 weeks of observation.

BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache