Migraine Attack Pain Phase Prediction Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 2 trial groupsGroup A: Patients with episodic migraine
Group B: Control patients
Trial outcomes
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.
Time frame
From the beginning of treatment, which is the initial visit, to 2 months of follow-upSecondary outcomes
1
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.
Time frame
From the beginning of treatment, which is the initial visit, to 2 months of follow-up2
Individualized prediction algorithm
Implement an individualized prediction algorithm that allows real-time prediction of the symptomatic phase of the migraine attack.
Time frame
From the beginning of treatment, which is the initial visit, to 2 months of follow-up3
Effectiveness of the prediction model
Measure the effectiveness of the prediction model both at the individual level and in a large group of patients.
Time frame
From the beginning of treatment, which is the initial visit, to 2 months of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead sponsor
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
Source ClinicalTrials.gov