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NCT Number: NCT06507150

AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance

Migraine affects 1 in 7 people globally, significantly impacting quality of life and economic productivity. Despite its prevalence, limited awareness leads to misdiagnosis, inadequate treatment, and stigmatization. AI can enhance migraine management through improved diagnosis, prediction, and personalized education. The primary objective of this study is to determine if adding AI-assisted migraine education to standard education improves patients' understanding of their condition more effectively.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano

Lugano, Switzerland

Location status: Recruiting

Location contact

Mallucci

CONTACT

[email protected]

+41 91 811 69 21

About this study

Migraine affecting approximately 1 in 7 individuals globally, significantly impacts quality of life and economic productivity due to its associated healthcare and social burdens. Despite its prevalence, awareness and understanding of migraine remain limited, contributing to misdiagnosis, inadequate treatment, and the perpetuation of stigmatization.

Artificial Intelligence (AI) may advance migraine management by improving diagnosis, prediction, and educational outreach. AI applications are currently being employed in diagnosing migraines more accurately by analyzing comprehensive patient data, thus differentiating migraine from other types of headaches. Additionally, AI algorithms predict migraine episodes, enabling preemptive measures. They also streamline medication management through reminders and monitor patient adherence, which is crucial for preventing medication overuse and optimizing treatment outcomes.

Moreover, AI can bridge the educational gap in migraine understanding. By using adaptive learning technologies, AI platforms can deliver personalized educational content, tailored to an individual's knowledge level and learning pace, enhancing understanding and engagement. This approach not only facilitates better management of the condition but also promotes a broader societal awareness essential for destigmatizing migraine.

The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 65 years at the time of signing the informed consent
  • Newly diagnosis of migraine, confirmed through the medical chart
  • The participant must be capable of giving signed informed consent
  • Access to a laptop, computer, smartphone, or tablet

Exclusion criteria

  • Insufficient knowledge of the protocol language (italian)
  • Patients with cognitive impairment and/or unable to use or access the AI-powered learning platform developed in this study.
  • Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage)

Treatment and study plan

AI-assisted migraine education (AIME)

Other

AIME Group will undergo the established migraine education plus AI-assisted education.

Primary outcomes

  1. The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.

    Time frame: 3 months

    Difference in the proportion of correct responses to a set of 20 migraine-related questions via the Migraine Intel Quotient test score (MiQ score) between Standard Migraine Education (SME Group) and the AI-assisted migraine education added to Standard Migraine Education (AIME group) at 3 months after baseline.

Secondary outcomes

  1. Investigate if the two types of educations have persistent effect over time up to 6 months.

    Time frame: 6 months

    To assess changes in the MiQ score from baseline to 3 months and to 6 months, and from 3 months to 6 months in the SME group and AIME group.

  2. Evaluate the participants' subjective perception of each education experience

    Time frame: 6 months

    To report patients' evaluation of learning experience at 3 and 6 months after baseline in both SME and AIME groups by 10 Visual Analog Scale (VAS) scoring, and comparison between groups at each timepoint

  3. Investigate migraine clinical course following either education interventions

    Time frame: 6 months

    To assess changes in the number of monthly migraine days, migraine intensity, and migraine duration as well as the HIT-6 and MIDAS scores at 3 and 6 months after baseline in SME and AIME groups, and between SME and AIME groups at each time point.

  4. Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions

    Time frame: 6 months

    To describe frequency and type of AEs occurring during the study period in SME and AIME groups.education interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Mallucci, Prof. Dr.ssa med.

CONTACT

[email protected]

+41 91 811 69 21

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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