Intracranial Pressure During Migraine

• Conditions: Menstrual Migraine
• Interventions: Other: Intracranial pressure variations

• Registration Number: NCT03152305
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.

Detailed Description

Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Study Timeline

• Study Start: 2014-07-21
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 18 to 50 non menopausal women
• Menstrual migraine
• Using a triptan as usual treatment to relieve attacks
• Usual triptan efficacy although recurrence is possible

Exclusion Criteria

• Disease of the ear
• Intracranial hypertension
• Chronic daily headache
• Use of topiramate or acetazolamide
• Triptans used more than 10 days/month
• Analgesic drug used more than 15 days/month
• Uncontrolled high blood pressure
• BMI >30
• Ongoing allergic rhinitis or flu

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with menstrual migraine	Intracranial pressure variations	Womens presenting with regular menstrual migraine treated with triptans will be included in the study.
Matched control	Intracranial pressure variations	The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Primary Outcome Measures

Name	Time	Method
Intracranial pressure variations	during menstrual migraine attacks	Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women

Secondary Outcome Measures

Name	Time	Method
Relationships between ICP variations and clinical parameters	during menstrual migraine attacks	Age, BMI, pain intensity, pulsating pain, allodynia, nausea, photophobia, phonophobia, dizziness, tinnitus
Relationships between ICP variations and pain relief	during menstrual migraine attacks

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Auvergne, France