NCT06459635 Migraine Attack Pain Phase Prediction Study
| NCT ID | NCT06459635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-10-09 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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\'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.
Contact & Investigator
Ana Beatriz Gago Veiga
PRINCIPAL INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Frequently Asked Questions
Who can join the NCT06459635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06459635 currently recruiting?
Yes, NCT06459635 is actively recruiting participants. Contact the research team at anabeatriz.gago@salud.madrid.org for enrollment information.
Where is the NCT06459635 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06459635 clinical trial?
NCT06459635 is sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. The principal investigator is Ana Beatriz Gago Veiga at Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. The trial plans to enroll 70 participants.
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