Cerebri Biofeedback Feasibility Trial

NCT05454319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-14

No results posted yet for this study

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

DEVICE

Biofeedback

Home-based biofeedback with medical device

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER
  • Norwegian University of Science and Technology

    collaborator OTHER
  • Nordic Brain Tech AS

    lead OTHER_GOV

Principal Investigators

  • Tore W Meisingset, MD, PhD · St. Olavs Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-09-27
Completion
2022-09-27

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454319 on ClinicalTrials.gov