NCT05454319

Cerebri Biofeedback Feasibility Trial

A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nordic Brain Tech AS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine. In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. By using biofeedback, bodily signals that are thought to be associated with migraines, are measured. During the treatment, one sensor is attached on 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 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.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DEVICE	Biofeedback	Home-based biofeedback with medical device

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2022-07-12
• Last updated: 2022-11-14

Locations

1 site across 1 country: Norway