Validation of a Questionnaire for Allodynia in Migraine.

NCT04580641 | Unknown

• 1 other identifier: RNI 2018 MOISSET (Q-MIGAL)
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 14

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.

Conditions

Migraine

Keywords

migraine; allodynia; photophobia; phonophobia; osmophobia; central sensitization

Outcome Measures

Primary Outcomes (1)

• Predictive factors of allodynia/hypersensitivity in subjects with migraine

  Correlations between scores on specific questionnaires evaluating allodynia/hypersensitivity (cutaneous allodynia with the questionnaire by Lipton et al., 2008, osmophobia with a home-made questionnaire rated from 0 to 4, photophobia with the questionnaire by Choi et al., 2009, phonophobia with the questionnaire by Khalfa et al., 2002), patients characteristics (age, sex, Body mass index, habits, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).

  baseline

Secondary Outcomes (4)

• Predictive factors of cutaneous allodynia in subjects with migraine

  baseline

• Predictive factors of photophobia in subjects with migraine

  baseline

• Predictive factors of phonophobia in subjects with migraine

  baseline

• Predictive factors of osmophobia in subjects with migraine

  baseline

Study Arms (1)

Subjects with migraine

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Subjects with migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects fulfilling 2018 international headache society criteria for migraine

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (14)

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

Annecy, 74000, France

Location

Cabinet de Neurologie

Clermont-Ferrand, 63000, France

Location

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

Clermont-Ferrand, 63000, France

Location

CHU de Clermont-Ferrand, Service de Neurologie

Clermont-Ferrand, 63000, France

Location

CH Emile Roux Le Puy en Velay, Service de Neurologie

Le Puy-en-Velay, 43000, France

Location

CHU de Lille, Service de Neurologie

Lille, France

Location

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

Lyon, 69000, France

Location

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

Marseille, 13000, France

Location

CHU de Montpellier, Service de Neurologie

Montpellier, 34000, France

Location

CHU de Nantes, Service de Neurologie

Nantes, 44000, France

Location

CHU de Nice, Département Evaluation et Traitement de la Douleur

Nice, 06000, France

Location

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

Paris, 75000, France

Location

CHU de Rouen, Service de Neurologie

Rouen, 76000, France

Location

CH de Vichy, Service de Neurologie

Vichy, 03200, France

Location

Related Publications (3)

• 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.

  PMID: 19298545 BACKGROUND

• 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.

  PMID: 18059010 BACKGROUND

• 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.

  PMID: 12499770 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Hyperalgesia; Photophobia; Hyperacusis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Eye Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xavier Moisset, MD, PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre, PharmD

CONTACT

04 73 754 963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-09

Locations

FR (14)