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

NCT ID: NCT07233941

Last Updated: 2026-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Migraine Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danilo A Montisano, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Neurologico Carlo Besta

Locations

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Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Danilo A Montisano, MD

Role: primary

+ 39 02.2394

Alessandra Parisi, PHD

Role: backup

0039.02.2394

References

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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.

Reference Type BACKGROUND
PMID: 14651415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11843865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28847155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1511992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26350071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32493204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38252898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26924634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35861637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12815497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21691143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2076086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Other Identifiers

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CogMIG

Identifier Type: -

Identifier Source: org_study_id

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