Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables (CogMIG)

February 9, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
The overall objective is to define the neuropsychological profile of patients with migraine and evaluate its association with: psychological outcome measures (anxiety-depressive symptoms, pain catastrophizing, excessive worry, and coping strategies); the clinical profile of migraine; the prodromal, ictal, or interictal phase of the migraine attack; pharmacological therapy; and detoxification treatment in patients with migraine associated with medication overuse headache.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged between 18 and 65 years who suffer from migraines

Description

Inclusion Criteria:

  • Written informed consent.
  • Patients aged between 18 and 65 years.
  • Diagnosis of migraine according to the International Classification of Headache Disorders (ICHD-3) criteria.
  • Patients with a history of migraine for at least one year, to ensure the stability of the condition.
  • Stability of ongoing treatment for at least 3 months at baseline.
  • Understanding of the Italian language.

Exclusion Criteria:

  • Severe medical or psychiatric conditions (depression, schizophrenia, psychosis) documented by specific previous diagnoses.
  • A history of alcohol or drug abuse.
  • Primary sensory deficits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functioning
Time Frame: 2 years
Neuropsychological test scores in migraine patients and proportion of participants with cognitive performance significantly different from age- and education-adjusted normative data.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functions and psychological, clinical aspects
Time Frame: 2 years
Correlation between cognitive performance scores and validated measures of anxiety/depression, pain catastrophizing, worry, coping strategies, headache-related impact and disability, and sleep quality in migraine patients.
2 years
Cognitive functions and different pharmacological treatments
Time Frame: 2 years
Differences in cognitive test performance scores among groups of migraine patients receiving different pharmacological treatments
2 years
Cognitive functions and medication overuse headache
Time Frame: 2 years
Change in cognitive test performance scores from pre-detoxification to post-detoxification treatment in patients with migraine and medication overuse headache.
2 years
Cognitive functions in the different phases of migraine
Time Frame: 2 years
Comparison of cognitive test performance scores between ictal and interictal migraine phases and across different durations of disease.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

  • Principal Investigator: Danilo A Montisano, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogMIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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