NCT07136740

BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache

BioTenCer: a Randomized, Wait-list Controlled Study to Assess the Safety and Efficacy of the Cerebri-biofeedback Device as Preventive Treatment in Adult Participants With Frequent and Chronic Tension Type Headache.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Helse Nord-Trøndelag HF · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial, BioTenCer, is a clinical study to test the efficacy and safety of the app-based biofeedback treatment, Cerebri-TTH, for tension type headache in adults. Bodily signals that are thought to be associated with TTH are measured by sensors during biofeedback. During the treatment, one sensor is placed on the skin above the upper trapezius muscle fibers to measure shoulder and neck muscle tension and one sensor is attached to the index finger to measure peripheral skin temperature and heart rate variability. By getting on-screen feedback on the phone, the user can learn techniques to reduce muscle tension, and increase finger temperature and heart rate variability. Reduced muscle tension, as well as an increase in finger temperature and heart rate variability is a sign of relaxation and a deactivation of the autonomous nervous system, which can lead to less intensity and fewer days of TTH. The aim of the study is to investigate the safety and efficacy of biofeedback treatment using Cerebri-TTH compared to wait-list controls. In this study, the investigators will randomize 300 adults with frequent and chronic TTH. All participants will complete a minimum of 4 weeks of daily headache diary entries in the Cerebri-TTH app. This will serve as the "baseline" measurements. Subsequently, the participants will be randomized to either the treatment group or the wait-list group. The treatment group will conduct daily biofeedback sessions (one session has a duration of 10 minutes) for 12 weeks. The wait-list group does not receive any specific treatment for 12 weeks but serves as an important basis for comparison to evaluate the treatment effect. 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. Similarly, the intervention arm can contribute with an additional 12 weeks of eDiary recordings if they are willing. Participants in both groups (the treatment group and the wait-list control group) must complete daily registrations in the headache diary included in the app. 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. AUC is calculated from a curve of the duration and intensity of headaches. Secondary key endpoints include the change in intensity of TTH, the change in duration of TTH, the change in mean number of days with TTH, the change in consumption of acute medication for TTH and the number, of participants with at least 30%, 50%, 75% and 100% reduction in mean Area-Under-the headache Curve (AUC). Preventive treatments for TTH, both drug and non-drug, have limited effects and potentially numerous side effects. If the biofeedback app proves to be effective, it may represent a useful and viable treatment option for TTH patients, that is readily available and unlikely to cause unwanted side effects. Number of Participants: the investigators will randomize 300 adult patients with TTH, with 150 participants randomized to each arm. The study consists of two arms. There is a run-in screening period of 4 weeks for both arms, and a treatment/waitlist period of 12 weeks. Subsequently, an extended treatment period of 12 weeks is offered to the waitlist control group. The participants in the treatment are arm are asked to contribute to an additional 12 weeks of daily eDairy registration explore the headache status and safety aspects after ended biofeedback training. The total duration of study participation for each participant is 16 weeks for the intervention arm and for the wait-list control arm which includes the screening/inclusion visit, a run-in period of 4 weeks without study intervention, a 12-week treatment/waitlist period with 3 planned telephone follow-ups before a final visit. An additional 12 weeks extension is offered participants, and in such cases the final visit is placed at the end of the extension phase. Subjects will complete daily app-based biofeedback sessions of 10 minutes per session for 12 weeks as the study intervention

Conditions

• Tension Type Headache

Interventions

Type	Name	Description
DEVICE	Cerebri-TTH biofeedback	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.
OTHER	headache diary	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-08-22
• Last updated: 2025-08-22