Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2023-10-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with episodic migraine
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.
No interventions assigned to this group
Control patients
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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Hospital Vall d'Hebron
OTHER
Hospital Donostia
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital Clínico Universitario Lozano Blesa
OTHER
Hospital Universitario La Fe
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Responsible Party
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Principal Investigators
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Ana Beatriz Gago Veiga
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Locations
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Hospital Universitario de La Princesa
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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3513
Identifier Type: -
Identifier Source: org_study_id
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