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Home-based Biofeedback for the Prevention of Migraine

NCT05616741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Nordic Brain Tech AS

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-06-19
Completion
2024-09-23

Countries

  • Norway

Study Locations

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Entities

Diseases

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 NCT05616741 on ClinicalTrials.gov