Validation of a Questionnaire for Allodynia in Migraine. (Q-MIGAL)

October 2, 2020 updated by: University Hospital, Clermont-Ferrand

Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France, 74000
        • CH d'Annecy, Centre d'Etude et de Traitement de la Douleur
        • Contact:
        • Principal Investigator:
          • Pierric Giraud, MD
      • Clermont-Ferrand, France, 63000
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand, Service de Neurologie
        • Contact:
        • Principal Investigator:
          • Xavier MOISSET, MD, PhD
        • Sub-Investigator:
          • Mélissa ZUEL, MD
      • Le Puy-en-Velay, France, 43000
        • CH Emile Roux Le Puy en Velay, Service de Neurologie
        • Contact:
        • Principal Investigator:
          • Jérémy DASSA, MD
      • Lille, France
        • CHU de Lille, Service de Neurologie
      • Lyon, France, 69000
        • CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie
        • Contact:
        • Principal Investigator:
          • Geneviève DEMARQUAY, MD
      • Marseille, France, 13000
        • Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur
        • Contact:
        • Principal Investigator:
          • Anne DONNET, MD, PhD
      • Montpellier, France, 34000
      • Nantes, France, 44000
      • Nice, France, 06000
        • CHU de Nice, Département Evaluation et Traitement de la Douleur
        • Contact:
        • Principal Investigator:
          • Michel LANTERI-MINET, MD, PhD
      • Paris, France, 75000
        • Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie
        • Principal Investigator:
          • Caroline ROOS, MD
        • Sub-Investigator:
          • Jérome MAWET, MD
        • Contact:
      • Rouen, France, 76000
      • Vichy, France, 03200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects fulfilling 2018 international headache society criteria for migraine

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with migraine
No medical intervention. All included subjects will filled in the questionnaire concerning migraine characteristics and associated symptoms.
Other: Questionnaire
A self-administered questionnaire will be completed by each study subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors of allodynia/hypersensitivity in subjects with migraine
Time Frame: baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factors of cutaneous allodynia in subjects with migraine
Time Frame: baseline
Correlations between score on the 12-item Allodynia Symptom Checklist (Lipton et al., 2008) (score from 0 to 24 with higher values indicating higher level of allodynia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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
Predictive factors of photophobia in subjects with migraine
Time Frame: baseline
Correlations between scores on two specific questionnaires evaluating photophobia (Choi et al., 2009; binary score for presence or absence of photophobia and home-made questionnaire with score from 0 to 4 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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
Predictive factors of phonophobia in subjects with migraine
Time Frame: baseline
Correlations between scores on a questionnaire evaluating phonophobia (Khalfa et al. 2002, score from 0 to 42 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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
Predictive factors of osmophobia in subjects with migraine
Time Frame: baseline
Correlations between scores on a specific home-made questionnaire evaluating osmophobia (score from 0 to 4 with higher values indicating higher level of osmophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Xavier Moisset, MD, PhD, CHU de Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2018 MOISSET (Q-MIGAL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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