BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache

NCT07136740 | Not Yet Recruiting

• 2 other identifiers: HelseNTHF24/07853
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tension Type Headache

Keywords

biofeedback; tension type headache; therapist independent treatment

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  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

  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

  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.

  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

  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.

  From day 1 up to 38 weeks.

Other Outcomes (10)

• To investigate the proportion of participants with at least 50% reduction in TTH duration and/or intensity from baseline to treatment between the treatment and control groups.

  From day 1 up to 38 weeks.

• To investigate the proportion of participants with at least 75% reduction in TTH duration and/or intensity from baseline to treatment between the treatment and control groups

  From day 1 up to 38 weeks.

• To investigate the proportion of participants with at least 100% reduction in TTH duration and/or intensity from baseline to treatment between the treatment and control groups

  From day 1 up to 38 weeks.

Study Arms (2)

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.

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.

Other: headache diary

Interventions

Cerebri-TTH biofeedback DEVICE

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.

Treatment group

headache diary OTHER

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.

Treatment group; wait-list group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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.
• 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.
• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• University Hospital, Akershus: collaborator
• Haukeland University Hospital: collaborator

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tore Wergeland Meisingset, MD, PhD, Assc. Prof.

  Helse Nordtrøndelag Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tore Wergeland Meisingset, MD, PhD, Assc. Prof

CONTACT

+4747358725; tore.w.meisingset@ntnu.no

Kristina Devik, MD

CONTACT

+4798833255; kristina.devik@helse-nordtrondelag.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08