BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache (NCT07136740) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
300 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Subjects diagnosed with trigeminal autonomic cephalalgias and cranial neuralgias.
* Subjects with secondary headache conditions with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing the area under-the-headache curve (AUC)
Timeframe: From day 1 up to 38 weeks.
2
To describe the treatment-emergent adverse events encountered during the investigation (include treatment emergent adverse events, ADEs, SADEs, and USADEs).
Timeframe: From randomization day-1 up to 34 weeks.