Migraine Attack Pain Phase Prediction Study (PREDI-CRISIS)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status: Enrolling

Conditions: Migraine With Aura; Migraine Disorders; Migraine Headache; Migraine Without Aura; Migraine

Study type: Observational

Funder types: Other

Identifiers

NCT06459635

3513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

Patients with episodic migraine

Description:

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

Description:

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).