Migraine Attack Pain Phase Prediction Study

Migraine Clinical Trial

— PREDI-CRISIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459635
• Other study ID #: 3513
• Status: Recruiting
• Start date: October 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: Ana Beatriz Gago Veiga
• Phone: +34 915202416
• Email: anabeatriz.gago[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Migraine Headache
• Migraine With Aura
• Migraine without Aura

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (7)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Hospital Clínico Universitario de Valladolid, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Donostia, Hospital Universitario La Fe, Hospital Universitario Marqués de Valdecilla, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & 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 20 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Secondary	Individualized prediction algorithm	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
Secondary	Effectiveness of the prediction model	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