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New treatment option for Tension Type Headache
Official title BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
ClinicalTrials.gov ID: NCT07136740
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
- people diagnosed with trigeminal autonomic cephalalgias and cranial neuralgias.
- people with secondary headache conditions with the exception of medication overuse headache (MOH) as defined in the ICHD-3 criteria that undergo a...
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
- people diagnosed with trigeminal autonomic cephalalgias and cranial neuralgias.
- people with secondary headache conditions with the exception of medication overuse headache (MOH) as defined in the ICHD-3 criteria that undergo a successful 8 weeks acute medication stop, and does not overuse...
- Use of concurrent TTH preventive medication, with the exception of stable dose (≥3 months or 5 half-lives, whichever is longer) monotherapy of TTH preventive medication.
- Use of prophylactic medication with known prophylactic effect on other headache disorders, whatever the indication, with the exception of stable dose (≥3 months or 5 half-lives, whichever is longer) monotherapy of any...
- people taking opioids (\>3 days per month) or barbiturates at the time of screening.
- Reduced sensibility, hearing or vision to a degree that impairs proper use of the app.
- Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator.
- Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator.
- Use of non-pharmacological preventive treatment, that in the opinion of the investigator is likely to interfere with the evaluation of the biofeedback treatment strategy under investigation. Stable non-pharmacological...
- Previous or current use of biofeedback equipment.
- Other pain conditions, not intended to be treated in this study, that in the opinion of the investigator could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints
- High probability neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.
- Have within 6 months of enrolment a significant untreated addiction to dependency-producing medications, alcohol, or illicit drugs.
- Abnormal pain behaviour, inappropriate medication-use and/or unresolved psychiatric illness, that in the opinion of the investigator are significant enough to impact perception of pain, compliance with intervention...
- Subject is currently participating or planning to participate in another clinical investigation.
- Subject who is unlikely to follow Clinical Investigation Plan or where treatment seems futile in the opinion of the Investigator or have demonstrated an inability to sufficiently adhere to headache diary entries...
The study team makes the final eligibility decision.
Where it's taking place
- Namsos, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Namsos, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.