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

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Migraine

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04580641
RNI 2018 MOISSET (Q-MIGAL)

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

Subjects with migraine
Description:
No medical intervention. All included subjects will filled in the questionnaire concerning migraine characteristics and associated symptoms.
Treatment:
Other: Questionnaire

Trial contacts and locations

14

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Central trial contact

Lise Laclautre, PharmD

Data sourced from clinicaltrials.gov

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