BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache
ConditionTension Type Headache
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelse Nord-Trøndelag HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cerebri-TTH biofeedback
DeviceCerebri-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 diary
Other interventionParticipants 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 groups
300 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 2 interventions
Group B: wait-list groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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)
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
Time frame
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).
A description of the frequency and severity of treatment- emergent adverse events, ADEs, SADEs, and USADEs).
Time frame
From randomization day-1 up to 34 weeks.Secondary outcomes
1
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
Time frame
From day 1 up to 38 weeks.2
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.
Time frame
From day 1 up to 38 weeks.3
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.
Time frame
From day 1 up to 38 weeks.4
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
Time frame
From day 1 up to 38 weeks.Other outcomes
1
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.
Difference in number of treatment responders (≥ 50% 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.
Time frame
From day 1 up to 38 weeks.2
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
Difference in number of treatment responders (≥ 75% 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.
Time frame
From day 1 up to 38 weeks.3
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
Difference in number of treatment responders (100% 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.
Time frame
From day 1 up to 38 weeks.4
Patient preference for treatment
12 weeks post-intervention the participant is asked to rate a benefit/tolerability ratio on an 11 point NRS scale. Similarly, a benefit/feasibility score will be assessed on a similar 11 point scale
Time frame
From day 1 up to 38 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Helse Nord-Trøndelag HF
Lead sponsor
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
University Hospital, Akershus
Collaborator
Haukeland University Hospital
Collaborator
Source ClinicalTrials.gov