Can a smartphone app cut migraine days? new trial says yes
NCT ID NCT05616741
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a home-based biofeedback app called Cerebri in 279 adults with episodic migraine. Participants used the app daily for 10 minutes, along with sensors to track muscle tension, heart rate, and finger temperature. The goal was to see if this approach could reduce the number of migraine days compared to a wait-list group. The trial is complete and focused on safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cerebri biofeedback device (app with sensors for muscle tension, heart rate, and temperature)
- What this could lead to
- If it works, this could offer a drug-free, at-home option to reduce migraine days for people with episodic migraine.
- What could go wrong
- This is a completed trial, but the effect may be modest and not work for everyone. Biofeedback requires daily commitment, and results may not apply to chronic migraine.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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279 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Sep 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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%).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Akershus University Hospital HF
Lørenskog, Akershus, 1478, Norway
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Haukeland University Hospital HF
Bergen, 5053, Norway
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St.Olavs Hospital HF
Trondheim, Norway
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University Hospital of North Norway
Tromsø, Norway
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