NCT05616741

Home-based Biofeedback for the Prevention of Migraine

A Randomized, Wait-list Controlled Trial of Daily, Home-based Biofeedback Therapy Using Cerebri for the Prevention of Migraine Attacks in Adults With Episodic Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Nordic Brain Tech AS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test an app-based biofeedback treatment in adults with migraine. The aim of the study is to investigate the safety and effectiveness of biofeedback treatment using the medical device Cerebri, compared to wait-list controls. Participants will perform 10 minutes biofeedback daily, in addition to daily registrations in the headache diary. Wait-list controls will complete daily registrations in the headache diary during the same period. Researchers will compare the reduction in the number of days with migraine from baseline per 28-day period between treatment group and the wait-list group.

Detailed description

This trial, BioCer, is a clinical study to test the effectiveness and safety of the app-based biofeedback treatment, Cerebri, for migraines in adults. Bodily signals that are thought to be associated with migraines are measured by sensors during biofeedback. During the treatment, one sensor is attached to the shoulder to measure activity in the shoulder and neck muscles and one sensor is attached to the index finger to measure 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 nervous system, which can lead to fewer and less serious migraine attacks. The aim of the study is to investigate the safety and effectiveness of biofeedback treatment using Cerebri compared to wait-list controls. In this study, the investigators will recruit 286 adults with episodic migraines. All participants will complete one month of daily headache diary entries in the Cerebri app without any specific treatment. 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 of 10 minutes duration 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. 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 number of days with migraine per 28-day period. The reduction in the number of migraine days will be compared between the treatment group and the wait-list group. Secondary endpoints include the change in intensity of headaches, the change in consumption of acute medication for migraine, and the number of participants with at least a 30% reduction in the number of migraine days. There is a wide range of preventive treatments for migraines, both drug and non-drug, but many 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 episodic migraine patients, that is readily available and unlikely to cause unwanted side effects.

Conditions

• Migraine

Interventions

Type	Name	Description
DEVICE	Cerebri biofeedback	Daily use of a mobile application connected with two wireless sensors for measurement of muscle tension, heart rate variability, and peripheral finger temperature, to be used for home-based biofeedback treatment.
OTHER	Cerebri headache diary	Daily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-06-19
• Completion: 2024-09-23
• First posted: 2022-11-15
• Last updated: 2025-09-18

Locations

4 sites across 1 country: Norway