Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06459635

Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine

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

70

Participants Needed

1

Research Sites

13 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

Researchers are studying the ability to predict the pain phase of migraine attacks in patients with episodic migraine. This research focuses on identifying early warning signs through premonitory symptoms and continuous monitoring of hemodynamic variables using a wearable device. The study aims to develop personalized prediction algorithms for migraine attacks based on these real-time measurements. Since 2013, this line of research has been ongoing at the Hospital de La Princesa in collaboration with universities in Madrid and has led to several scientific publications and invention patents. Participants diagnosed with episodic migraine, who experience between 4 and 10 migraine attacks per month and have had migraine for at least one year, will be enrolled. Over a maximum of two months, they will use a wearable device to monitor their hemodynamic data continuously and record detailed clinical information about each migraine attack. The collected data will then be used to create individualized algorithms that aim to predict the onset of migraine pain. During the study, participants will be closely monitored for up to two months while they record their migraine characteristics and physiological data. Researchers will assess the development and effectiveness of the prediction model, measuring its ability to anticipate migraine pain onset. The study also involves regular follow-up to ensure participant adherence and to collect comprehensive data for analysis. The total participation time is approximately two months, during which researchers aim to generate predictive strategies for migraine attacks.

CONDITIONS

Brief 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 and 69 years
  • Diagnosed with migraine by a headache neurologist according to ICHD-3 criteria
  • History of migraine for at least 1 year
  • Normal neurological examination
  • Provided informed consent
  • Able to describe clinical situation and headache characteristics
  • Average of 10 to 14 migraine days per month in prior three months
  • Able to use smartphone-type electronic devices
  • Able to complete two months of study follow-up
Not Eligible

You will not qualify if you...

  • Presence of other headache types except analgesic overuse headache
  • Cognitive deficiency or other conditions preventing correct study participation
  • Neurological abnormalities on examination
  • Pregnancy or breastfeeding
  • Known heart disease, bronchopathy, Sjögren's syndrome, diabetes mellitus, hypo/hyperthyroidism
  • Use of pacemakers, neurostimulators, or other electronic devices affecting biometric data
  • Anatomical issues preventing use of monitoring device
  • Expected changes in migraine preventive or usual treatment during study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 months

Participants monitor their hemodynamic variables with a wearable device and record all clinical characteristics of their migraine attacks.

Continuous monitoring using a wearable device during the period

Trial Site Locations

Total: 1 location

1

Hospital Universitario de La Princesa

Madrid, Spain, 28006

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Research Team

A

Ana Beatriz Gago Veiga

I

Iris Fernández Lázaro

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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Published Research Related To This Trial