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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: AI-assisted migraine education (AIME)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Mallucci, Prof. Dr.ssa med.; Phone Number: +41 91 811 69 21; Email: giulia.mallucci@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland
    • Recruiting
    • Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano
    • Contact: Mallucci; Phone Number: +41 91 811 69 21; Email: giulia.mallucci@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIME - AI-assisted migraine education; Intervention group: it receives AI-assisted migraine education in addition to standard migraine education	Other: AI-assisted migraine education (AIME); AIME Group will undergo the established migraine education plus AI-assisted education.
No Intervention: SME -Standard Migraine Education; Control group: it receives standard migraine education only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate if the two types of educations have persistent effect over time up to 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.	6 months
Evaluate the participants' subjective perception of each education experience	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	6 months
Investigate migraine clinical course following either education interventions	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.	6 months
Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions	To describe frequency and type of AEs occurring during the study period in SME and AIME groups.education interventions	6 months

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: EOC.NSI.HA.2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No