NCT07233941

Brief 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 interictal phase of the migraine attack; pharmacological therapy; and detoxification treatment in patients with migraine associated with medication overuse headache.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Sep 2025May 2027

Study Start

First participant enrolled

September 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 11, 2026

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

November 14, 2025

Last Update Submit

February 9, 2026

Conditions

MigraineMigraine Disease

Keywords

migrainecognitioncognitive impairment

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (4)

  • Cognitive functions and psychological, clinical aspects

    2 years

  • Cognitive functions and different pharmacological treatments

    2 years

  • Cognitive functions and medication overuse headache

    2 years

  • Cognitive functions in the different phases of migraine

    2 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 18 and 65 years who suffer from migraines

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

RECRUITING

Related Publications (14)

  • 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.

    PMID: 14651415BACKGROUND

  • 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.

    PMID: 11843865BACKGROUND

  • 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.

    PMID: 28847155BACKGROUND

  • 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.

    PMID: 1511992BACKGROUND

  • 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.

    PMID: 26350071BACKGROUND

  • 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.

    PMID: 32493204BACKGROUND

  • 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.

    PMID: 38252898BACKGROUND

  • 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.

    PMID: 26924634BACKGROUND

  • 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.

    PMID: 35861637BACKGROUND

  • 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.

    PMID: 12815497BACKGROUND

  • 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.

    PMID: 21691143BACKGROUND

  • 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.

    PMID: 6880820BACKGROUND

  • 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.

    PMID: 2076086BACKGROUND

  • 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.

    PMID: 2748771BACKGROUND

MeSH Terms

Conditions

Migraine DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Danilo A Montisano, MD

    Fondazione IRCCS Istituto Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 11, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)