NCT05616741

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

October 25, 2022

Last Update Submit

September 12, 2025

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Efficacy of intervention in treatment group compared to the wait-list control group in reducing the frequency of migraine days

    Change in the mean number of migraine days from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group

    4 months

Secondary Outcomes (5)

  • Early onset efficacy of intervention in treatment group compared to the wait-list control group in reducing the frequency of migraine days

    4 months

  • Efficacy of intervention in treatment group compared to the wait-list control group in reducing migraine intensity

    4 months

  • Proportion of participants with at least 30% reduction in migraine days between the treatment and wait-list control groups

    4 months

  • Change in acute migraine drug use between the treatment and wait-list control groups

    4 months

  • Change in subject-reported headache-related disability from baseline to treatment between the treatment and control groups

    4 months

Other Outcomes (7)

  • Change in weekly migraine days during the treatment period (for trend analyses)

    4 months

  • Change in 28-day period headache days

    4 months

  • Adherence to protocol

    4 months

  • +4 more other outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Cerebri biofeedback and Cerebri headache diary

Device: Cerebri biofeedbackOther: Cerebri headache diary

Waitlist control group

OTHER

Only Cerebri headache diary

Other: Cerebri headache diary

Interventions

Cerebri biofeedbackDEVICE

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.

Treatment group
Cerebri headache diaryOTHER

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

Treatment groupWaitlist control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Akershus University Hospital HF

Lørenskog, Akershus, 1478, Norway

Location

Haukeland University Hospital HF

Bergen, 5053, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St.Olavs Hospital HF

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 40909914DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tore Meisingset, MD, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is an open-label, randomized, wait-list controlled multicenter trial with a run-in phase.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 15, 2022

Study Start

January 1, 2023

Primary Completion

June 19, 2024

Study Completion

September 23, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(4)