Migraine Attack Pain Phase Prediction Study
Recruiting · NCT06459635 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
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.
Where it is running
1 location listed.
- Hospital Universitario de La Princesa - Madrid, Madrid, Spain