Intracranial Pressure During Migraine

Menstrual Migraine Clinical Trial

— MigICP  

Official title:

Measure of Intracranial Pressure Variations During Migraine Attacks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152305
• Other study ID #: CHU-331
• Secondary ID: 2014-A00042-45
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 11, 2017
• Start date: July 21, 2014
• Est. completion date: July 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Migraine
• Migraine Disorders

Intervention

Other:
• Intracranial pressure variations
Self-measure of ICP will be performed outside and during menstrual migraine attacks.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial pressure variations	Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women	during menstrual migraine attacks
Secondary	Relationships between ICP variations and clinical parameters	Age, BMI, pain intensity, pulsating pain, allodynia, nausea, photophobia, phonophobia, dizziness, tinnitus	during menstrual migraine attacks
Secondary	Relationships between ICP variations and pain relief		during menstrual migraine attacks