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

NCT06507150 | Recruiting

• 1 other identifier: EOC.NSI.HA.2401
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Outcome Measures

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.

  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 Outcomes (4)

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

  6 months

• Evaluate the participants' subjective perception of each education experience

  6 months

• Investigate migraine clinical course following either education interventions

  6 months

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

  6 months

Study Arms (2)

AIME - AI-assisted migraine education

EXPERIMENTAL

Intervention group: it receives AI-assisted migraine education in addition to standard migraine education

Other: AI-assisted migraine education (AIME)

SME -Standard Migraine Education

NO INTERVENTION

Control group: it receives standard migraine education only

Interventions

AI-assisted migraine education (AIME) OTHER

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

AIME - AI-assisted migraine education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Giulia Mallucci, Prof. Dr.ssa med.

CONTACT

+41 91 811 69 21; giulia.mallucci@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, dr

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 18, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-01

Locations

CH (1)