BioTenCer: Biofeedback as Preventive Treatment in Tension Type Headache

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

Interventions

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.

OTHER

headache diary

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.

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Nord-Trøndelag HF

  lead OTHER

Principal Investigators

• Tore Wergeland Meisingset, MD, PhD, Assc. Prof. · Helse Nordtrøndelag Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-12-31

Completion

2027-12-31