Validation of a Questionnaire for Allodynia in Migraine.

NCT ID: NCT04580641

Last Updated: 2020-10-08

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

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-09-30

Brief Summary

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Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

Detailed Description

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The prevalence of migraine is around 15% worldwide (GBD 2016, Lancet Neurol 2018). During attacks, and even between attacks, especially when migraine frequency is high, many subjects with migraine present with photophobia, phonophobia, osmophobia or allodynia. These symptoms are though to correspond to central sensitization and can be found in animal models of migraine (Boyer et al., Pain 2017; Dallel et al., Cephalalgia 2018).

These 4 symptoms have been studied separately in previous studies but to date, there is no overall questionnaire evaluating these 4 sub-types of hypersensitivity. The investigators have constituted a questionnaire based on previous validated questionnaires that have been translated into French (Lipton et al., 2008 for cutaneous allodynia; Choi et al., 2009 for photophobia), a previous questionnaire validated in French (Khalfa et al, 2002 for phonophobia) and created a few questions for each of the 4 symptoms, including osmophobia.

Conditions

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Migraine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with migraine

No medical intervention. All included subjects will filled in the questionnaire concerning migraine characteristics and associated symptoms.

Questionnaire

Intervention Type OTHER

A self-administered questionnaire will be completed by each study subject

Interventions

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Questionnaire

A self-administered questionnaire will be completed by each study subject

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects fulfilling 2018 international headache society criteria for migraine.
* Age \> 17 years.
* Written consent.

Exclusion Criteria

* Presence of neurological comorbidities that could lead to sensorial or sensitive abnormalities
* Presence of dermatological comorbidities that could lead to sensorial or sensitive abnormalities
* Presence of ENT comorbidities that could lead to sensorial or sensitive abnormalities
* Significant cognitive dysfunction precluding proper completion of the self-administered questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Moisset, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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CH d'Annecy, Centre d'Etude et de Traitement de la Douleur

Annecy, , France

Site Status

Cabinet de Neurologie

Clermont-Ferrand, , France

Site Status

CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur

Clermont-Ferrand, , France

Site Status

CHU de Clermont-Ferrand, Service de Neurologie

Clermont-Ferrand, , France

Site Status

CH Emile Roux Le Puy en Velay, Service de Neurologie

Le Puy-en-Velay, , France

Site Status

CHU de Lille, Service de Neurologie

Lille, , France

Site Status

CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie

Lyon, , France

Site Status

Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur

Marseille, , France

Site Status

CHU de Montpellier, Service de Neurologie

Montpellier, , France

Site Status

CHU de Nantes, Service de Neurologie

Nantes, , France

Site Status

CHU de Nice, Département Evaluation et Traitement de la Douleur

Nice, , France

Site Status

Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie

Paris, , France

Site Status

CHU de Rouen, Service de Neurologie

Rouen, , France

Site Status

CH de Vichy, Service de Neurologie

Vichy, , France

Site Status

Countries

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France

Central Contacts

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Lise Laclautre, PharmD

Role: CONTACT

04 73 754 963 ext. 33

Facility Contacts

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Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

Lise Laclautre, PharmD

Role: primary

0473754963

Lise Laclautre, PharmD

Role: primary

0473754963 ext. 33

References

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Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27.

Reference Type BACKGROUND
PMID: 19298545 (View on PubMed)

Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58. doi: 10.1002/ana.21211.

Reference Type BACKGROUND
PMID: 18059010 (View on PubMed)

Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42. doi: 10.1159/000067570.

Reference Type BACKGROUND
PMID: 12499770 (View on PubMed)

Other Identifiers

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RNI 2018 MOISSET (Q-MIGAL)

Identifier Type: -

Identifier Source: org_study_id

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