Migraine Attack Pain Phase Prediction Study

NCT06459635 | Recruiting

• 1 other identifier: 3513
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Migraine; Migraine Headache; Migraine Disorders; Migraine Without Aura; Migraine With Aura

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Posibility of predict the onset of pain in a migraine attack

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

• Individualized prediction algorithm

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

• Effectiveness of the prediction model

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

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• User-level management capacity of "smartphone" type electronic devices.
• Be able to complete two months of study follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Hospital Vall d'Hebron: collaborator
• Hospital Donostia: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Hospital Universitario La Fe: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 30310310 RESULT

• 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.

  PMID: 26134103 RESULT

MeSH Terms

Conditions

Migraine Disorders; Migraine without Aura; Migraine with Aura; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Beatriz Gago Veiga

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Beatriz Gago Veiga

CONTACT

+34 915202416; anabeatriz.gago@salud.madrid.org

Iris Fernández Lázaro

CONTACT

irisfdezlaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: October 9, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

ES (1)