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MigrainePREDI-CRISISNCT06459635

Migraine Attack Pain Phase Prediction Study

An observational study of Migraine and Migraine Headache, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Migraine, Migraine Headache, Migraine Disorders
How many people
70 participants
Where
1 siteSpain
Study dates
9 Oct 2023to Dec 2026
How long will I take part?
2 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

Other trials in Spain

About this study

Official title: Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine

The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.

Read the detailed description

Patients with episodic migraine will be recruited from the monographic headache clinics of the 7 centers participating in the study. These patients, for a maximum period of 2 months, must monitor their hemodynamic variables with a wearable device and record all the clinical characteristics of their migraine attacks. Subsequently, with these records, an individualized algorithm will be created for each patient that aims to predict the onset of the migraine attack.

Keywords
Migraine, Headache, Predict, Prediction, headache prediction, predict headache, migraine prediction, predict migraine, migraine attacks, migraine attack, headache attack, migraine attack prediction, predict migraine attack, prediction algorithm, algorithm
Medical subject headings
Migraine Disorders, Migraine without Aura, Migraine with Aura, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06459635
Study groupRoleWhat they receive
Patients with episodic migrainePatients with episodic migraine who present between 4 and 10 migraine attacks per month. These patients must have a diagnosis of migraine by a headache neurologist and according to the criteria proposed by ICHD-3. In addition, they must present at least 1 year of evolution of the migraine, as well as a normal neurological examination and have given their informed consent.
Control patientsPeople who have never had a headache episode with migraine characteristics. These may present, at most, one episode per month of headache with non-migraine characteristics in the last 3 months. In turn, they should not have a family history of migraine (1st and 2nd degree).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of a prediction strategy for the onset of migraine

    Develop a prediction strategy for the onset of migraine attacks in patients with episodic migraine, based on hemodynamic and clinical variables of migraine attacks.

    Measured: From the beginning of treatment, which is the initial visit, to 2 months of follow-up

Secondary outcomes (3)

  1. Posibility of predict the onset of pain in a migraine attack

    To analyze whether it is possible to predict the onset of pain in a migraine attack, through ambulatory and non-invasive monitoring of physiological variables.

    Measured: From the beginning of treatment, which is the initial visit, to 2 months of follow-up

  2. Individualized prediction algorithm

    Implement an individualized prediction algorithm that allows real-time prediction of the symptomatic phase of the migraine attack.

    Measured: From the beginning of treatment, which is the initial visit, to 2 months of follow-up

  3. Effectiveness of the prediction model

    Measure the effectiveness of the prediction model both at the individual level and in a large group of patients.

    Measured: From the beginning of treatment, which is the initial visit, to 2 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start9 Oct 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
70 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459635
Sponsor's protocol ID
3513
Acronym
PREDI-CRISIS
Status last verified
Jan 2026
First submitted
5 Jun 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers. This decision is based on data protection and confidentiality requirements in accordance with applicable European and national regulations (including GDPR). Given that this is a multicentre observational study conducted in routine clinical practice, access to IPD is restricted to the study investigators for the purposes of the predefined analyses. Any potential secondary use of the dataset would only be considered in fully anonymized form and subject to prior ethical approval and compliance with applicable data protection legislation.

Publications

  • Gago-Veiga AB, Pagan J, Henares K, Heredia P, Gonzalez-Garcia N, De Orbe MI, Ayala JL, Sobrado M, Vivancos J. To what extent are patients with migraine able to predict attacks? J Pain Res. 2018 Sep 27;11:2083-2094. doi: 10.2147/JPR.S175602. eCollection 2018.

    PubMed 30310310

  • Pagan J, De Orbe MI, Gago A, Sobrado M, Risco-Martin JL, Mora JV, Moya JM, Ayala JL. Robust and Accurate Modeling Approaches for Migraine Per-Patient Prediction from Ambulatory Data. Sensors (Basel). 2015 Jun 30;15(7):15419-42. doi: 10.3390/s150715419.

    PubMed 26134103

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Migraine Headache, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. 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 Spain. 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?

This study is still under way. Results are not available in the source record yet.

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?

Development of a prediction strategy for the onset of migraine (time frame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up). 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 NCT06459635, which also lists 2 linked publications.

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 23 Sep 2026.

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