BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache

Cerebri-TTH biofeedback device is a therapist-independent home-based smartphone treatment application (app). Cerebri-TTH is a medical device in risk class IIa, according to MDR, and includes two non-invasive wireless sensors and a smartphone application. Both sensors shall be in contact with the skin: one sensor is applied on the index finger and measures heart rate (HR), heart rate variability (HRV) and peripheral skin temperature. The second sensor is applied on the trapezius muscle using adhesive electrodes and measures muscle tension. The sensors transmit the measurements to the user's smartphone where the user is instructed to perform a biofeedback session. The sensors are to be used for 10 minutes per session per day. The user can choose to use the device more frequently if desired - up to 6 sessions per day.

"Participants randomized to the wait-list arm, are instructed to keep daily eDairy entries for 12 weeks.~The wait list control group will be offered active treatment for 12 weeks after the initial 12-week wait-list period is completed in an extension phase."