Migraine Attack Pain Phase Prediction Study (PREDI-CRISIS)

June 10, 2024 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with episodic migraine
Patients 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 patients
People 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Develop a prediction strategy for the onset of migraine attacks in patients with episodic migraine, based on hemodynamic and clinical variables of migraine attacks.
From the beginning of treatment, which is the initial visit, to 2 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posibility of predict the onset of pain in a migraine attack
Time Frame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
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.
From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Individualized prediction algorithm
Time Frame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Implement an individualized prediction algorithm that allows real-time prediction of the symptomatic phase of the migraine attack.
From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Effectiveness of the prediction model
Time Frame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Measure the effectiveness of the prediction model both at the individual level and in a large group of patients.
From the beginning of treatment, which is the initial visit, to 2 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Collaborators

Hospital Universitario La Fe
Hospital Vall d'Hebron
Hospital Universitario Marqués de Valdecilla
Hospital Clínico Universitario de Valladolid
Hospital Universitario Donostia
Hospital Clínico Universitario Lozano Blesa

Investigators

  • Principal Investigator: Ana Beatriz Gago Veiga, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data may be shared upon reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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