Clinical trial NCT04580641: Validation of a Questionnaire for Allodynia in Migraine.
Official title: Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Keywords: migraine
allodynia
photophobia
phonophobia
osmophobia
central sensitization
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects fulfilling 2018 international headache society criteria for migraine

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive factors of allodynia/hypersensitivity in subjects with migraine
timeFrame: baseline
Secondary outcomes:
measure: Predictive factors of cutaneous allodynia in subjects with migraine
timeFrame: baseline
measure: Predictive factors of photophobia in subjects with migraine
timeFrame: baseline
measure: Predictive factors of phonophobia in subjects with migraine
timeFrame: baseline
measure: Predictive factors of osmophobia in subjects with migraine
timeFrame: baseline
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH d'Annecy, Centre d'Etude et de Traitement de la Douleur
city: Clermont-Ferrand
country: France
facility: Cabinet de Neurologie
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand, Service de Neurologie
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux Le Puy en Velay, Service de Neurologie
city: Lille
country: France
facility: CHU de Lille, Service de Neurologie
city: Lyon
country: France
facility: CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur
city: Montpellier
country: France
facility: CHU de Montpellier, Service de Neurologie
city: Nantes
country: France
facility: CHU de Nantes, Service de Neurologie
city: Nice
country: France
facility: CHU de Nice, Département Evaluation et Traitement de la Douleur
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie
city: Rouen
country: France
facility: CHU de Rouen, Service de Neurologie
city: Vichy
country: France
facility: CH de Vichy, Service de Neurologie
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Xavier Moisset, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.