Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06459635

Migraine Attack Pain Phase Prediction Study

Led by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Updated on 2024-06-14

70

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

F

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Lead Sponsor

H

Hospital Vall d'Hebron

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Migraine Attack Pain Phase Prediction Study

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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, Sj�gren'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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario de La Princesa

Madrid, Spain, 28006

Actively Recruiting

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Research Team

A

Ana Beatriz Gago Veiga

CONTACT

I

Iris Fernández Lázaro

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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