Neuropsychological and cognitive profile in adults with migraine
Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables
This project will test how thinking skills and psychological factors (like anxiety, depression, worry, and coping) relate to migraine in adults who have had migraine for at least one year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07233941 on ClinicalTrials.gov |
What this trial studies
This observational study will perform standardized neuropsychological testing and collect measures of anxiety, depressive symptoms, pain catastrophizing, excessive worry, and coping strategies in people with migraine. Investigators will examine how cognitive functioning relates to migraine clinical features, attack phase (prodromal, ictal, interictal), current pharmacological treatment, and detoxification in cases of medication overuse headache. Eligible participants are adults 18–65 with an ICHD-3 migraine diagnosis and stable treatment for at least three months, excluding those with severe psychiatric or medical comorbidities, substance abuse, or primary sensory deficits. All assessments are conducted at Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy, using validated instruments and standardized protocols.
Who should consider this trial
Good fit: Adults aged 18–65 with an ICHD-3 diagnosis of migraine for at least one year, stable treatment for three months, able to understand Italian, and without severe medical/psychiatric disorders or substance abuse are ideal candidates.
Not a fit: People with severe psychiatric illnesses, a history of alcohol or drug abuse, primary sensory deficits, or those who cannot understand Italian are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the findings could help identify cognitive and psychological patterns linked to migraine and guide more personalized management strategies.
How similar studies have performed: Previous observational research has reported mixed evidence of cognitive changes in people with migraine, so this study builds on existing but not definitive findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Danilo A Montisano, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.