Tension Type HeadacheBioTenCerNCT07136740
BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
A study testing Cerebri-TTH biofeedback and headache diary in people with Tension Type Headache, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tension Type Headache
- What is being tested?
- Cerebri-TTH biofeedback and headache diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 17 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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 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.
Show all 21Show fewer
- 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 preventive medication.
- Subjects 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 treatments for other indications than TTH that is not likely to interfere, is allowed if it is kept unaltered during study participation.
- 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 and/or ability to evaluate treatment outcome.
- 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 (<70%).
- This 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/or photophobia and phonophobia, and, in some cases, preceded by unilateral, fully-reversible central nervous system symptoms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
This trial, BioTenCer, is a clinical study to test the efficacy and safety of the app-based biofeedback treatment, Cerebri-TTH, for tension type headache in adults. Bodily signals that are thought to be associated with TTH are measured by sensors during biofeedback. During the treatment, one sensor is placed on the skin above the upper trapezius muscle fibers to measure shoulder and neck muscle tension and one sensor is attached to the index finger to measure peripheral skin temperature and heart rate variability. By getting on-screen feedback on the phone, the user can learn techniques to reduce muscle tension, and increase finger temperature and heart rate variability. Reduced muscle tension, as well as an increase in finger temperature and heart rate variability is a sign of relaxation and a deactivation of the autonomous nervous system, which can lead to less intensity and fewer days of TTH. The aim of the study is to investigate the safety and efficacy of biofeedback treatment using Cerebri-TTH compared to wait-list controls. In this study, the investigators will randomize 300 adults with frequent and chronic TTH. All participants will complete a minimum of 4 weeks of daily headache diary entries in the Cerebri-TTH app. This will serve as the "baseline" measurements. Subsequently, the participants will be randomized to either the treatment group or the wait-list group. The treatment group will conduct daily biofeedback sessions (one session has a duration of 10 minutes) for 12 weeks. 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. The 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. Similarly, the intervention arm can contribute with an additional 12 weeks of eDiary recordings if they are willing. Participants in both groups (the treatment group and the wait-list control group) must complete daily registrations in the headache diary included in the app. 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. AUC is calculated from a curve of the duration and intensity of headaches. Secondary key endpoints include the change in intensity of TTH, the change in duration of TTH, the change in mean number of days with TTH, the change in consumption of acute medication for TTH and the number, of participants with at least 30%, 50%, 75% and 100% reduction in mean Area-Under-the headache Curve (AUC). Preventive treatments for TTH, both drug and non-drug, have limited effects and potentially numerous side effects. If the biofeedback app proves to be effective, it may represent a useful and viable treatment option for TTH patients, that is readily available and unlikely to cause unwanted side effects.
Number of Participants: the investigators will randomize 300 adult patients with TTH, with 150 participants randomized to each arm.
The study consists of two arms. There is a run-in screening period of 4 weeks for both arms, and a treatment/waitlist period of 12 weeks. Subsequently, an extended treatment period of 12 weeks is offered to the waitlist control group. The participants in the treatment are arm are asked to contribute to an additional 12 weeks of daily eDairy registration explore the headache status and safety aspects after ended biofeedback training. The total duration of study participation for each participant is 16 weeks for the intervention arm and for the wait-list control arm which includes the screening/inclusion visit, a run-in period of 4 weeks without study intervention, a 12-week treatment/waitlist period with 3 planned telephone follow-ups before a final visit. An additional 12 weeks extension is offered participants, and in such cases the final visit is placed at the end of the extension phase. Subjects will complete daily app-based biofeedback sessions of 10 minutes per session for 12 weeks as the study intervention
- Conditions
- Tension Type Headache
- Being tested
- Cerebri-TTH biofeedback, headache diary
- Keywords
- biofeedback, tension type headache, therapist independent treatment
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebri-TTH biofeedbackDevice
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.
headache diaryOther
Participants randomized to the wait-list arm, are instructed to keep daily eDairy entries for 12 weeks.
The 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cerebri-TTH biofeedback; Other: headache diary |
| 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. Receives: Other: headache diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Difference in the mean AUC from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: From day 1 up to 38 weeks.
To describe the treatment-emergent adverse events encountered during the investigation (include treatment emergent adverse events, ADEs, SADEs, and USADEs).
A description of the frequency and severity of treatment- emergent adverse events, ADEs, SADEs, and USADEs).
Measured: From randomization day-1 up to 34 weeks.
Secondary outcomes (9)
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing the number of TTH days
Difference in number of days with TTH per 4 weeks in the baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing mean headache intensity
Difference in mean headache intensity from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group.
Measured: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing mean headache duration.
Difference in mean headache duration from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group.
Measured: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing the use of rescue medication
Difference in use of rescue medication from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: From day 1 up to 38 weeks.
To investigate patient-reported impact of headaches and headache treatment in the treatment group as compared to the control group.
Difference in mean HURT-3 score in the treatment group as compared to the wait-list control group.
Measured: From day 1 up to 38 weeks.
To investigate patient-reported symptoms of anxiety and depression in the treatment group as compared to the control group.
Difference in mean Hospital Anxiety and Depression score (HADs) in the treatment group as compared to the wait-list control group.
Measured: From day 1 up to 38 weeks.
To investigate the proportion of participants with at least 30% reduction in TTH duration and/or intensity from baseline to treatment between the treatment and control groups.
Difference in number of treatment responders (≥ 30% reduction in the mean AUC) from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: From day 1 up to 38 weeks.
To determine the frequency of device deficiencies
Occurrence of device deficiencies.
Measured: From randomization day 1 up to 34 weeks.
Determine fetal outcome and the frequency of pregnancy complications
Occurrence of pregnancy complications and report fetal outcome data
Measured: From day 1 up to 38 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start17 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus, Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Tore Wergeland Meisingset, MD, PhD, Assc. Prof., Principal investigator, Helse Nordtrøndelag Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136740
- Sponsor's protocol ID
- 731620
- Other IDs
- 24/07853
- Acronym
- BioTenCer
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07136740
- Acronym / sponsor ID
- BioTenCer / 731620
- Conditions
- Tension Type Headache
- Keywords
- biofeedback, tension type headache, therapist independent treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, University Hospital, Akershus, Haukeland University Hospital
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial, BioTenCer, is a clinical study to test the efficacy and safety of the app-based biofeedback treatment, Cerebri-TTH, for tension type headache in adults. Bodily signals that are thought to be associated with TTH are measured by sensors during biofeedback. During the treatment, one sensor is placed on the skin above the upper trapezius muscle fibers to measure shoulder and neck muscle tension and one sensor is attached to the index finger to measure peripheral skin temperature and heart rate variability. By getting on-screen feedback on the phone, the user can learn techniques to reduce muscle tension, and increase finger temperature and heart rate variability. Reduced muscle tension, as well as an increase in finger temperature and heart rate variability is a sign of relaxation and a deactivation of the autonomous nervous system, which can lead to less intensity and fewer days of TTH. The aim of the study is to investigate the safety and efficacy of biofeedback treatment using Cerebri-TTH compared to wait-list controls. In this study, the investigators will randomize 300 adults with frequent and chronic TTH. All participants will complete a minimum of 4 weeks of daily headache diary entries in the Cerebri-TTH app. This will serve as the "baseline" measurements. Subsequently, the participants will be randomized to either the treatment group or the wait-list group. The treatment group will conduct daily biofeedback sessions (one session has a duration of 10 minutes) for 12 weeks. 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. The 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. Similarly, the intervention arm can contribute with an additional 12 weeks of eDiary recordings if they are willing. Participants in both groups (the treatment group and the wait-list control group) must complete daily registrations in the headache diary included in the app. 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. AUC is calculated from a curve of the duration and intensity of headaches. Secondary key endpoints include the change in intensity of TTH, the change in duration of TTH, the change in mean number of days with TTH, the change in consumption of acute medication for TTH and the number, of participants with at least 30%, 50%, 75% and 100% reduction in mean Area-Under-the headache Curve (AUC). Preventive treatments for TTH, both drug and non-drug, have limited effects and potentially numerous side effects. If the biofeedback app proves to be effective, it may represent a useful and viable treatment option for TTH patients, that is readily available and unlikely to cause unwanted side effects.
Number of Participants: the investigators will randomize 300 adult patients with TTH, with 150 participants randomized to each arm.
The study consists of two arms. There is a run-in screening period of 4 weeks for both arms, and a treatment/waitlist period of 12 weeks. Subsequently, an extended treatment period of 12 weeks is offered to the waitlist control group. The participants in the treatment are arm are asked to contribute to an additional 12 weeks of daily eDairy registration explore the headache status and safety aspects after ended biofeedback training. The total duration of study participation for each participant is 16 weeks for the intervention arm and for the wait-list control arm which includes the screening/inclusion visit, a run-in period of 4 weeks without study intervention, a 12-week treatment/waitlist period with 3 planned telephone follow-ups before a final visit. An additional 12 weeks extension is offered participants, and in such cases the final visit is placed at the end of the extension phase. Subjects will complete daily app-based biofeedback sessions of 10 minutes per session for 12 weeks as the study intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Cerebri-TTH biofeedback, Other: headache diaryTreatment 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. |
| wait-list group | Placebo comparator | Other: headache diaryThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebri-TTH biofeedbackCerebri-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. | Device | Treatment group |
| headache diaryParticipants randomized to the wait-list arm, are instructed to keep daily eDairy entries for 12 weeks. The 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. | Other | Treatment group, wait-list group |
Primary outcome
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)
Time frame: From day 1 up to 38 weeks.
Difference in the mean AUC from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
To describe the treatment-emergent adverse events encountered during the investigation (include treatment emergent adverse events, ADEs, SADEs, and USADEs).
Time frame: From randomization day-1 up to 34 weeks.
A description of the frequency and severity of treatment- emergent adverse events, ADEs, SADEs, and USADEs).
9 secondary outcomes
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing the number of TTH days
Time frame: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing mean headache intensity
Time frame: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing mean headache duration.
Time frame: From day 1 up to 38 weeks.
To investigate the efficacy of Cerebri-TTH in treatment group as compared to wait list control group in reducing the use of rescue medication
Time frame: From day 1 up to 38 weeks.
To investigate patient-reported impact of headaches and headache treatment in the treatment group as compared to the control group.
Time frame: From day 1 up to 38 weeks.
To investigate patient-reported symptoms of anxiety and depression in the treatment group as compared to the control group.
Time frame: From day 1 up to 38 weeks.
To investigate the proportion of participants with at least 30% reduction in TTH duration and/or intensity from baseline to treatment between the treatment and control groups.
Time frame: From day 1 up to 38 weeks.
To determine the frequency of device deficiencies
Time frame: From randomization day 1 up to 34 weeks.
Determine fetal outcome and the frequency of pregnancy complications
Time frame: From day 1 up to 38 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tore Wergeland Meisingset, MD, PhD, Assc. Prof. principal investigator
Helse Nordtrøndelag Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebri-TTH biofeedback and headache diary in people with Tension Type Headache, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tore Wergeland Meisingset, MD, PhD, Assc. Prof (+4747358725, tore.w.meisingset@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From day 1 up to 38 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.