MigraineBioCerNCT05616741
Home-based Biofeedback for the Prevention of Migraine
A study testing Cerebri biofeedback and Cerebri headache diary in people with Migraine, run by Nordic Brain Tech AS at 4 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Cerebri biofeedback and Cerebri headache diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Jan 2023to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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%).
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital HF
Bergen, 5053
Akershus University Hospital HF
Lørenskog, Akershus, 1478
University Hospital of North Norway
Tromsø
St.Olavs Hospital HF
Trondheim
About this study
Official title: A Randomized, Wait-list Controlled Trial of Daily, Home-based Biofeedback Therapy Using Cerebri for the Prevention of Migraine Attacks in Adults With Episodic Migraine
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.
Read the 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
- Being tested
- Cerebri biofeedback, Cerebri headache diary
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Cerebri headache diaryOther
Daily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Cerebri biofeedback and Cerebri headache diary Receives: Device: Cerebri biofeedback; Other: Cerebri headache diary |
| Waitlist control group | Other | Only Cerebri headache diary Receives: Other: Cerebri headache diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change in the mean number of migraine days from baseline to the first two 28-day periods during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: 4 months
Efficacy of intervention in treatment group compared to the wait-list control group in reducing migraine intensity
Change in the mean intensity of migraine/headache using 11-point scale (0-10), where high score means high migraine intensity. Change will be assessed from baseline to the last 28-day period during the treatment phase, in the treatment group as compared to the wait-list control group
Measured: 4 months
Proportion of participants with at least 30% reduction in migraine days between the treatment and wait-list control groups
Responder rate, defined as the number of participants with at least a 30% reduction in migraine days from baseline to the last 28-day period, in the treatment group as compared to the wait-list control group.
Measured: 4 months
Change in acute migraine drug use between the treatment and wait-list control groups
Change in acute migraine drug treatment use from baseline to the last 28-day period, in the treatment group as compared to the wait-list control group.
Measured: 4 months
Change in subject-reported headache-related disability from baseline to treatment between the treatment and control groups
Change in subject-reported headache-related disability measured by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) from baseline to the last 28-day period, in the treatment group as compared to the wait-list control group. The MSQ v2.1 contains 14 questions from three domains with six response alternatives ranging from "none of the time" to "all of the time". Low score indicates low amount of headache-related disability.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2023
- Primary completion19 Jun 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-label, randomized, wait-list controlled multicenter trial with a run-in phase.
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Brain Tech AS
- Sponsor type
- Other government
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital, University Hospital, Akershus, Haukeland University Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Tore Meisingset, MD, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616741
- Sponsor's protocol ID
- 502734
- Other IDs
- CIV-NO-22-08-040446
- Acronym
- BioCer
- Status last verified
- Sep 2025
- First submitted
- 25 Oct 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40909914
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Wait-list Controlled Trial of Daily, Home-based Biofeedback Therapy Using Cerebri for the Prevention of Migraine Attacks in Adults With Episodic Migraine
- ClinicalTrials.gov ID
- NCT05616741
- Acronym / sponsor ID
- BioCer / 502734
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Nordic Brain Tech ASOther government
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital, University Hospital, Akershus, Haukeland University Hospital, University Hospital of North Norway
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-label, randomized, wait-list controlled multicenter trial with a run-in phase.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Cerebri biofeedback, Other: Cerebri headache diaryCerebri biofeedback and Cerebri headache diary |
| Waitlist control group | Other | Other: Cerebri headache diaryOnly Cerebri headache diary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebri biofeedbackDaily 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. | Device | Treatment group |
| Cerebri headache diaryDaily registration of headache and medication with the Cerebri mobile application. This intervention is identical for both study arms. | Other | Treatment group, Waitlist control group |
Primary outcome
Efficacy of intervention in treatment group compared to the wait-list control group in reducing the frequency of migraine days
Time frame: 4 months
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
5 secondary outcomes
Early onset efficacy of intervention in treatment group compared to the wait-list control group in reducing the frequency of migraine days
Time frame: 4 months
Efficacy of intervention in treatment group compared to the wait-list control group in reducing migraine intensity
Time frame: 4 months
Proportion of participants with at least 30% reduction in migraine days between the treatment and wait-list control groups
Time frame: 4 months
Change in acute migraine drug use between the treatment and wait-list control groups
Time frame: 4 months
Change in subject-reported headache-related disability from baseline to treatment between the treatment and control groups
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 40909914Poole 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore Meisingset, MD, PhD principal investigator
St. Olavs Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebri biofeedback and Cerebri headache diary in people with Migraine, run by Nordic Brain Tech AS at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intervention in treatment group compared to the wait-list control group in reducing the frequency of migraine days (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.