Predicting migraine attack pain using wearable devices
Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine
This study is testing if a wearable device can help people with episodic migraines predict when their attacks will start by tracking their body signals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06459635 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict the onset of migraine attacks by monitoring patients' hemodynamic variables through a wearable device. Patients with episodic migraine will be recruited from specialized headache clinics and will track their migraine characteristics over a two-month period. The data collected will be used to develop individualized algorithms for predicting migraine attacks based on premonitory symptoms. This research is part of a long-term initiative by the Headaches Unit at Hospital de La Princesa in collaboration with local universities.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 to 69 with a diagnosis of high-frequency episodic migraine and the ability to use smartphone technology.
Not a fit: Patients with other types of headaches or cognitive impairments that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable patients to anticipate migraine attacks and manage their symptoms more effectively.
How similar studies have performed: Previous studies have shown promise in using wearable technology for headache prediction, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Hospital Universitario de La Princesa — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Beatriz Gago Veiga — Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Study coordinator: Ana Beatriz Gago Veiga
- Email: anabeatriz.gago@salud.madrid.org
- Phone: +34 915202416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.