Episodic MigraineCER-MIG-1NCT05454319
Cerebri Biofeedback Feasibility Trial
A study testing Biofeedback in people with Episodic Migraine, run by Nordic Brain Tech AS at 1 site in Norway.
Trial summary
The purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine. In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2022to 27 Sep 2022
- 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 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).
- Having kept a headache diary with at least 80% adherence as part of routine clinical care in the last 28-days prior to inclusion.
- 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 and confirmed in the clinical diary.
- 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
- Having a continuous background headache that never disappears completely.
- 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.
- Subjects with headaches attributed by the treating neurologist/physician as being medication overuse headache according to the ICHD-3.
- Subject with pathologies that inhibit use of the device according to the instructions for use (e.g., blindness, deafness).
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- Use of any concurrent preventive treatment (medications, meditation, physical therapy and psychotherapy as a headache treatment, acupuncture, etc.).
- Subjects who have previously failed three prophylactic pharmacological treatments.
- Subjects taking opioids (>3 days per month) or barbiturates at the time of screening.
- Subject participates in another clinical investigation.
- Alcohol overuse according to ICD-10-CM Code F10.1 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 (<80%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.
The purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine.
In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. By using biofeedback, bodily signals that are thought to be associated with migraines, are measured. During the treatment, one sensor is attached on 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 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.
- Conditions
- Episodic Migraine
- Being tested
- Biofeedback
- Keywords
- Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackDevice
Also called CEREBRI
Home-based biofeedback with medical device
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Treatment Group | Experimental | Medical device Receives: Device: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration
Extraction of data from headache diary and completed biofeedback sessions
Measured: 3 months
Secondary outcomes (6)
Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)
Mean mHealth app usability questionnaire (MAUQ) score at treatment week 1 and 12
Measured: 3 months
Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire
Modified System Usability Scale (SUS) questionnaire score at treatment weeks 1 and 12
Measured: 3 months
Initial estimates of efficacy and onset of efficacy assessed by number of migraine days
Change in the mean number of 28-day period migraine days from before treatment, to treatment weeks 1-4, weeks 5-8 and weeks 9-12.
Measured: 3 months
Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)
Change in self-reported treatment efficacy by the Patient Global Impression of Change Scale (PGIC) from before treatment to end-of-treatment
Measured: 3 months
Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
Change in subject-reported, headache-related disability measured using the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1), from before treatment to end-of-treatment
Measured: 3 months
Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use
Semi-structured interviews to evaluate design and ease of use of intervention, at treatment week 6 and 12, in a subset of subjects.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jun 2022
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
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 Episodic 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Brain Tech AS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tore W Meisingset, MD, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454319
- Sponsor's protocol ID
- 457654
- Acronym
- CER-MIG-1
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Poole AC, Winnberg IG, Simpson MR, Stubberud A, Vetvik KG, Bjork MH, Oie LR, Holmboe P, Olsen A, Tronvik E, Wergeland T. Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial. JMIR Hum Factors. 2025 Jun 9;12:e59622. doi: 10.2196/59622.
PubMed 40489633
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.
- ClinicalTrials.gov ID
- NCT05454319
- Acronym / sponsor ID
- CER-MIG-1 / 457654
- Conditions
- Episodic Migraine
- Keywords
- Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nordic Brain Tech ASOther government
- Collaborators
- St. Olavs Hospital, Norwegian University of Science and Technology
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 12 Jul 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 purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine.
In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. By using biofeedback, bodily signals that are thought to be associated with migraines, are measured. During the treatment, one sensor is attached on 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Treatment Group | Experimental | Device: BiofeedbackMedical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age 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).
- Having kept a headache diary with at least 80% adherence as part of routine clinical care in the last 28-days prior to inclusion.
- 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 and confirmed in the clinical diary.
- At least three months of experience with smartphone and access to an iOS or Android phone at home.
Key exclusion criteria (12 listed)
- Having a continuous background headache that never disappears completely.
- 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.
- Subjects with headaches attributed by the treating neurologist/physician as being medication overuse headache according to the ICHD-3.
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 |
|---|---|---|
| BiofeedbackAlso: CEREBRIHome-based biofeedback with medical device | Device | Biofeedback Treatment Group |
Primary outcome
Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration
Time frame: 3 months
Extraction of data from headache diary and completed biofeedback sessions
6 secondary outcomes
Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)
Time frame: 3 months
Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire
Time frame: 3 months
Initial estimates of efficacy and onset of efficacy assessed by number of migraine days
Time frame: 3 months
Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)
Time frame: 3 months
Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
Time frame: 3 months
Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use
Time frame: 3 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 14 Nov 2022.
- Derived from this study: PubMed 40489633Poole AC, Winnberg IG, Simpson MR, Stubberud A, Vetvik KG, Bjork MH, Oie LR, Holmboe P, Olsen A, Tronvik E, Wergeland T. Feasibility of a 12-Week, Therapist-Independent, Smartphone-Based Biofeedback Treatment for Episodic Migraine in Adults: Single-Center, Open-Label, 1-Armed Trial. JMIR Hum Factors. 2025 Jun 9;12:e59622. doi: 10.2196/59622.
- Individual participant dataSharing planned: Undecided
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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 W Meisingset, MD, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Episodic Migraine, run by Nordic Brain Tech AS at 1 site 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 7 inclusion and 12 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration (time frame: 3 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 NCT05454319, 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 14 Nov 2022.