Clinical trial NCT06459635: Migraine Attack Pain Phase Prediction Study
Official title: Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Hospital Donostia
name: Hospital Universitario Marqués de Valdecilla
name: Hospital Clínico Universitario Lozano Blesa
name: Hospital Universitario La Fe
name: Hospital Clínico Universitario de Valladolid
First posted: 2024-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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 \&#39;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

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.

Detailed 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.

Eligibility criteria: 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\&#39;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.

Primary outcomes:
measure: Development of a prediction strategy for the onset of migraine
timeFrame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Secondary outcomes:
measure: Posibility of predict the onset of pain in a migraine attack
timeFrame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
measure: Individualized prediction algorithm
timeFrame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
measure: Effectiveness of the prediction model
timeFrame: From the beginning of treatment, which is the initial visit, to 2 months of follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Ana Beatriz Gago Veiga
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.