Home-based Biofeedback for the Prevention of Migraine

NCT ID: NCT05616741

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-09-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Cerebri biofeedback and Cerebri headache diary

Group Type: EXPERIMENTAL

Cerebri biofeedback

Intervention Type: DEVICE

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.

Cerebri headache diary

Intervention Type: OTHER

Daily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms.

Waitlist control group

Only Cerebri headache diary

Group Type: OTHER

Cerebri headache diary

Intervention Type: OTHER

Daily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms.

Interventions

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.

Intervention Type: DEVICE

Cerebri headache diary

Daily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms.

Intervention Type: OTHER

Eligibility Criteria

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 per International 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 3 months prior to screening (as recalled by the subject). This frequency must be confirmed in the headache diary before randomization to treatment or wait-list control.
• At least three months of experience with smartphone and access to an iOS or Android phone at home.
• Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Onset of migraine before age 50 years.

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 the instructions 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 of stable 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 have previously attempted three or more prophylactic pharmacological treatments in adequate doses, without significant clinical effect.
• Subjects taking opioids (>3 days per month) or barbiturates at the time of screening.
• Subject participates in another clinical investigation or has participated in CER-MIG-1.
• Alcohol overuse or illicit drug use.
• Subject who is unlikely to follow Clinical Investigation Plan or where treatment seems futile in the opinion of the Investigator or have demonstrated an inability to sufficiently adhere to headache diary entries (<70%).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Nordic Brain Tech AS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tore Meisingset, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

Akershus University Hospital HF

Lørenskog, Akershus, Norway

Haukeland University Hospital HF

Bergen, , Norway

University Hospital of North Norway

Tromsø, , Norway

St.Olavs Hospital HF

Trondheim, , Norway

Countries

Norway

References

Poole AC, Stubberud A, Simpson M, Oie L, Skalstad ETV, Bjork MH, Kristoffersen ES, Vetvik KG, Olsen A, Larsen ICK, Linde M, Tronvik EA, Meisingset TW. Biofeedback therapy using Cerebri for the prevention of migraine attacks in adults with episodic migraine (BioCer): a randomized, wait-list controlled trial - the study protocol. F1000Res. 2025 Aug 29;13:775. doi: 10.12688/f1000research.149807.2. eCollection 2024.

Reference Type: DERIVED

PMID: 40909914 (View on PubMed)

Other Identifiers

CIV-NO-22-08-040446

Identifier Type: OTHER

Identifier Source: secondary_id

502734

Identifier Type: -

Identifier Source: org_study_id