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.
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.
• 18 years of age inclusive or older, at the time of signing the informed consent.
• A diagnosis of TTH according to the criteria of the International Classification of Headache Disorders 3rd edition (ICHD-3)
• History of at least 6 days or more with TTH per 28-day period in the 3 months prior to screening (as recalled by the subject).
• Frequency of at least 6 days or more with TTH per 28-day period, confirmed by daily diary entries in the baseline period.
• At least three months of experience with smartphone and access to an iOS or Android phone at home.
• Capability of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Onset of TTH (and migraine, if present) before the age of 50 years.
• The onset of TTH should be present for at least 1 year prior to inclusion.