BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
ConditionTension Type Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelse Nord-Trøndelag HF
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Subject does not master a Scandinavian language at a level sufficient to fully understand the written and verbal study information.
Subject is unable to differentiate TTH from other concomitant headaches.
A history of more than 1 migraine attack per month on average in the last year, as recalled by the patient.
Frequency of more than 1 migraine attack per month during the baseline period, as confirmed by daily diary entries.
Trial design
Treatments tested in this trial
- Cerebri-TTH biofeedback
- headache diary
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Helse Nord-Trøndelag HF
Lead sponsor
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
University Hospital, Akershus
Collaborator
Haukeland University Hospital
Collaborator
Source ClinicalTrials.gov