[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603455":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":48,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":26},{"fullName":5,"class":6},"Helse Nord-Trøndelag HF","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Treatment group is randomized to receive biofeedback treatment for 12 weeks. The intervention arm- treatment-group will be offered contribute with in an extension phase: an additional 12 weeks of eDiary recordings if they are willing.",[13,14],"Device: Cerebri-TTH biofeedback","Other: headache diary",{"label":16,"type":17,"description":18,"interventionNames":19},"wait-list group","PLACEBO_COMPARATOR","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. This group will keep daily headache diary for 12 weeks. placebo group will be offered Cerebri-TTH biofeedback in extension phase.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"headache diary","Participants randomized to the wait-list arm, are instructed to keep daily eDairy entries for 12 weeks.\n\nThe 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.",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Tore Wergeland Meisingset, MD, PhD, Assc. Prof.","Helse Nordtrøndelag Trust","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Tore Wergeland Meisingset, MD, PhD, Assc. Prof","CONTACT","+4747358725","tore.w.meisingset@ntnu.no",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Kristina Devik, MD","+4798833255","kristina.devik@helse-nordtrondelag.no",{"type":47,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[49,51,53,55],{"name":50,"class":6},"St. Olavs Hospital",{"name":52,"class":6},"University Hospital of North Norway",{"name":54,"class":6},"University Hospital, Akershus",{"name":56,"class":6},"Haukeland University Hospital","100603455","biotencer-biofeedback-as-preventive-treatment-in-tension-type-headache-100603455",false,"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.","BioTenCer","Inclusion Criteria:\n\n* 18 years of age inclusive or older, at the time of signing the informed consent.\n* A diagnosis of TTH according to the criteria of the International Classification of Headache Disorders 3rd edition (ICHD-3)\n* 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).\n* Frequency of at least 6 days or more with TTH per 28-day period, confirmed by daily diary entries in the baseline period.\n* At least three months of experience with smartphone and access to an iOS or Android phone at home.\n* 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.\n* Onset of TTH (and migraine, if present) before the age of 50 years.\n* The onset of TTH should be present for at least 1 year prior to inclusion.\n\nExclusion Criteria:\n\n* Subject does not master a Scandinavian language at a level sufficient to fully understand the written and verbal study information.\n* Subject is unable to differentiate TTH from other concomitant headaches.\n* A history of more than 1 migraine attack per month on average in the last year, as recalled by the patient.\n* Frequency of more than 1 migraine attack per month during the baseline period, as confirmed by daily diary entries.\n* Subjects diagnosed with trigeminal autonomic cephalalgias and cranial neuralgias.\n* Subjects 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 medication in the following 28 day period.\n* 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.\n* 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 preventive medication.\n* Subjects taking opioids (\\>3 days per month) or barbiturates at the time of screening.\n* Reduced sensibility, hearing or vision to a degree that impairs proper use of the app.\n* Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator.\n* Patients exhibiting a high degree of comorbidity and\u002For frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator.\n* 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 treatments for other indications than TTH that is not likely to interfere, is allowed if it is kept unaltered during study participation.\n* Previous or current use of biofeedback equipment.\n* 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\u002For confound evaluation of study endpoints\n* High probability neurological deterioration due to other medical conditions, that in the opinion of the investigator may confound outcome assessment.\n* Have within 6 months of enrolment a significant untreated addiction to dependency-producing medications, alcohol, or illicit drugs.\n* Abnormal pain behaviour, inappropriate medication-use and\u002For unresolved psychiatric illness, that in the opinion of the investigator are significant enough to impact perception of pain, compliance with intervention and\u002For ability to evaluate treatment outcome.\n* Subject is currently participating or planning to participate in another clinical investigation.\n* 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 (\\\u003C70%).\n\nThis study excludes patients with more than 1 migraine attack per month. A migraine attack is defined according to ICHD-3 criteria as attacks of unilateral, pulsating, moderate or severe headache lasting 4-72 hours that is aggravated by physical activity, associated with nausea and\u002For photophobia and phonophobia, and, in some cases, preceded by unilateral, fully-reversible central nervous system symptoms.","ALL","18 Years",{"count":68,"type":69},300,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nThe 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.",[75],"Tension Type Headache",[77,78,79],"biofeedback","tension type headache","therapist independent treatment","NOT_YET_RECRUITING","2025-08-21",{"date":83,"type":84},"2025-08-22","ACTUAL",{"date":86,"type":69},"2025-09-01",{"date":88,"type":69},"2027-12",{"name":5,"class":6}]