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Scientists aim to forecast migraine pain using wearable sensors and early symptoms

NCT ID NCT06459635

Knowledge-focused Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study explores whether migraine attacks can be predicted before the headache phase begins. Researchers will monitor people with episodic migraine (10–14 migraine days per month) using a wearable device that tracks heart rate and other body signals, along with a diary of early warning symptoms. The goal is to develop a personalized algorithm that could one day give patients a heads-up before pain strikes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a wearable device or app that warns people with migraine when an attack is about to begin, allowing earlier treatment.
What could go wrong
This is an early-stage observational study with only 70 participants. The prediction method may not work for everyone or may be too complex for daily use.

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.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged between 18 and 65 years with a diagnosis of episodic migraine who have between 4 and 14 days of headache per month. These patients will come from 7 Headache Units in Spain belonging to the following hospitals: • La Princesa University Hospital • Vall \'Hebron University Hospital • Marqués de Valdecilla University Hospital • Valladolid University Clinical Hospital • Donostia University Hospital • Lozano Blesa University Clinical Hospital • La Fe Polytechnic University Hospital

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age between 15 years and 69 years. * Diagnosed with migraine by a headache neurologist and according to the criteria proposed by ICHD-3. * History of migraine of at least 1 year of evolution. * Normal neurological examination. * Have given your informed consent. * Be able to describe your clinical situation and the characteristics of your headache. * Have an average of 10 to 14 migraine days per month in the three months prior to inclusion (high-frequency episodic migraine). * User-level management capacity of "smartphone" type electronic devices. * Be able to complete two months of study follow-up. Exclusion Criteria: * Presence of another type of headache, with the exception of headache due to excessive use of analgesic medication. * Cognitive deficiency or any other pathology that may prevent or make it difficult for the patient to perform the study correctly. * Neurological focus in the examination. * Pregnancy or breastfeeding period. * Patients with known heart disease or bronchopathy, Sjögren\'s syndrome, diabetes mellitus, or hypo/hyperthyroidism. * Carriers of pacemakers, neurostimulators or any other electronic device that is considered to make the interpretation of biometric records difficult. * Anatomical problem that makes the use of the device impossible. * Patients in whom it is expected that a change in migraine preventive treatment or other usual treatment will be possible during the study period.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder migraine with aura migraine without aura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine Migraine disorders Migraine headache Migraine with aura Migraine without aura

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario de La Princesa

    RECRUITING

    Madrid, Madrid, 28006, Spain

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