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MigraineCogMIGNCT07233941

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

An observational study of Migraine and Migraine Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine, Migraine Disease
How many people
150 participants
Where
1 siteItaly
Study dates
1 Sep 2025to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged between 18 and 65 years who suffer from migraines

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan

    Danilo A Montisano, MD, + 39 02.2394, danilo.montisano@istituto-besta.it

    Alessandra Parisi, PHD, 0039.02.2394, alessandra.parisi@istituto-besta.it

    Recruiting

Other trials in Italy

About this study

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.

Keywords
migraine, cognition, cognitive impairment
Medical subject headings
Migraine Disorders, Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive functioning

    Neuropsychological test scores in migraine patients and proportion of participants with cognitive performance significantly different from age- and education-adjusted normative data.

    Measured: 2 years

Secondary outcomes (4)

  1. Cognitive functions and psychological, clinical aspects

    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.

    Measured: 2 years

  2. Cognitive functions and different pharmacological treatments

    Differences in cognitive test performance scores among groups of migraine patients receiving different pharmacological treatments

    Measured: 2 years

  3. Cognitive functions and medication overuse headache

    Change in cognitive test performance scores from pre-detoxification to post-detoxification treatment in patients with migraine and medication overuse headache.

    Measured: 2 years

  4. Cognitive functions in the different phases of migraine

    Comparison of cognitive test performance scores between ictal and interictal migraine phases and across different durations of disease.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start1 Sep 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233941
Sponsor's protocol ID
CogMIG
Acronym
CogMIG
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193.

    PubMed 14651415

  • D'Amico D, Mosconi P, Genco S, Usai S, Prudenzano AM, Grazzi L, Leone M, Puca FM, Bussone G. The Migraine Disability Assessment (MIDAS) questionnaire: translation and reliability of the Italian version. Cephalalgia. 2001 Dec;21(10):947-52. doi: 10.1046/j.0333-1024.2001.00277.x.

    PubMed 11843865

  • Gil-Gouveia R, Martins IP. Clinical description of attack-related cognitive symptoms in migraine: A systematic review. Cephalalgia. 2018 Jun;38(7):1335-1350. doi: 10.1177/0333102417728250. Epub 2017 Aug 28.

    PubMed 28847155

  • Guerra LK, Rehfeldt IR, Lima MT, Petzl-Erler ML, de Messias IJ. BF and C3 genetic polymorphisms in Kaingang Indians from southern Brazil. Hum Hered. 1992;42(3):153-6. doi: 10.1159/000154058.

    PubMed 1511992

  • Gil-Gouveia R, Oliveira AG, Martins IP. The impact of cognitive symptoms on migraine attack-related disability. Cephalalgia. 2016 Apr;36(5):422-30. doi: 10.1177/0333102415604471. Epub 2015 Sep 8.

    PubMed 26350071

  • Vallesi A. On the utility of the trail making test in migraine with and without aura: a meta-analysis. J Headache Pain. 2020 Jun 3;21(1):63. doi: 10.1186/s10194-020-01137-y.

    PubMed 32493204

  • Pizer JH, Aita SL, Myers MA, Hawley NA, Ikonomou VC, Brasil KM, Hernandez KA, Pettway EC, Owen T, Borgogna NC, Smitherman TA, Hill BD. Neuropsychological Function in Migraine Headaches: An Expanded Comprehensive Multidomain Meta-Analysis. Neurology. 2024 Feb 27;102(4):e208109. doi: 10.1212/WNL.0000000000208109. Epub 2024 Jan 22.

    PubMed 38252898

  • Maleki N, Gollub RL. What Have We Learned From Brain Functional Connectivity Studies in Migraine Headache? Headache. 2016 Mar;56(3):453-61. doi: 10.1111/head.12756. Epub 2016 Feb 29.

    PubMed 26924634

  • Mondini S, Montemurro S, Pucci V, Ravelli A, Signorini M, Arcara G. Global Examination of Mental State: An open tool for the brief evaluation of cognition. Brain Behav. 2022 Aug;12(8):e2710. doi: 10.1002/brb3.2710. Epub 2022 Jul 21.

    PubMed 35861637

  • Stern Y. The concept of cognitive reserve: a catalyst for research. J Clin Exp Neuropsychol. 2003 Aug;25(5):589-93. doi: 10.1076/jcen.25.5.589.14571. No abstract available.

    PubMed 12815497

  • Nucci M, Mapelli D, Mondini S. Cognitive Reserve Index questionnaire (CRIq): a new instrument for measuring cognitive reserve. Aging Clin Exp Res. 2012 Jun;24(3):218-26. doi: 10.3275/7800. Epub 2011 Jun 20.

    PubMed 21691143

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

    PubMed 2076086

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Migraine Disease, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive functioning (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07233941, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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