Home-based Biofeedback for the Prevention of Migraine

Last updated: October 2, 2024
Sponsor: Nordic Brain Tech AS
Overall Status: Completed

Phase

N/A

Condition

Migraine (Adult)

Chronic Pain

Oral Facial Pain

Treatment

Cerebri headache diary

Cerebri biofeedback

Clinical Study ID

NCT05616741
502734
CIV-NO-22-08-040446
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age inclusive or older, at the time of signing the informed consent

  • Episodic migraines with or without aura diagnosed by a neurologist/physician perInternational Classification of Headache Disorders 3rd edition (ICHD-3).

  • History of at least 4 and up to 14 days of migraines per 28-day period in the 3months prior to screening (as recalled by the subject). This frequency must beconfirmed in the headache diary before randomization to treatment or wait-listcontrol.

  • At least three months of experience with smartphone and access to an iOS or Androidphone at home.

  • Capable of giving signed informed consent as described in Appendix 1 which includescompliance with the requirements and restrictions listed in the informed consentform (ICF) and in this protocol.

  • Onset of migraine before age 50 years.

Exclusion

Exclusion Criteria:

  • More than 14 days of headache (all types) per 28-day period.

  • Subjects diagnosed with trigeminal autonomic cephalalgias and neuralgias.

  • Subjects with secondary headache conditions.

  • Subject with pathologies that inhibit use of the device according to theinstructions for use (e.g., blindness, deafness).

  • Use of non-pharmacological preventive treatment (meditation, physical therapy,psychotherapy as a headache treatment, acupuncture, etc.), with the exception ofstable treatment for other indications than migraine

  • Use of concurrent migraine preventive medication, with the exception of stable dose (≥3 months) monotherapy of migraine preventive medication · Subjects who havepreviously attempted three or more prophylactic pharmacological treatments inadequate doses, without significant clinical effect.

  • Subjects taking opioids (>3 days per month) or barbiturates at the time ofscreening.

  • Subject participates in another clinical investigation or has participated inCER-MIG-1.

  • Alcohol overuse or illicit drug use.

  • Subject who is unlikely to follow Clinical Investigation Plan or where treatmentseems futile in the opinion of the Investigator or have demonstrated an inability tosufficiently adhere to headache diary entries (<70%).

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Cerebri headache diary
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
September 23, 2024

Study 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.

Connect with a study center

  • Akershus University Hospital HF

    Lørenskog, Viken 1478
    Norway

    Site Not Available

  • Haukeland University Hospital HF

    Bergen, 5053
    Norway

    Site Not Available

  • University Hospital of North Norway

    Tromsø,
    Norway

    Site Not Available

  • St.Olavs Hospital HF

    Trondheim,
    Norway

    Site Not Available

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