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Can a smartphone app cut migraine days? new trial says yes

NCT ID NCT05616741

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

279 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Akershus University Hospital HF

    Lørenskog, Akershus, 1478, Norway

  • Haukeland University Hospital HF

    Bergen, 5053, Norway

  • St.Olavs Hospital HF

    Trondheim, Norway

  • University Hospital of North Norway

    Tromsø, Norway

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