This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Intracranial Pressure During Migraine (MigICP)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT03152305
First received: May 11, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose
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.

Condition Intervention
Menstrual Migraine Other: Intracranial pressure variations

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Measure of Intracranial Pressure Variations During Migraine Attacks

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Intracranial pressure variations [ Time Frame: during menstrual migraine attacks ]
    Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women


Secondary Outcome Measures:
  • Relationships between ICP variations and clinical parameters [ Time Frame: during menstrual migraine attacks ]
    Age, BMI, pain intensity, pulsating pain, allodynia, nausea, photophobia, phonophobia, dizziness, tinnitus

  • Relationships between ICP variations and pain relief [ Time Frame: during menstrual migraine attacks ]

Estimated Enrollment: 60
Actual Study Start Date: July 21, 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women with menstrual migraine
Womens presenting with regular menstrual migraine treated with triptans will be included in the study.
Other: Intracranial pressure variations
Self-measure of ICP will be performed outside and during menstrual migraine attacks.
Matched control
The potential variations will be compared to the measures done on matched healthy women outside and during menses.
Other: Intracranial pressure variations
Self-measure of ICP will be performed outside and during menstrual migraine attacks.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03152305

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Contact: Pierre CLAVELOU pclavelou@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Contact: Pierre CLAVELOU       pclavelou@chu-clermontferrand.fr   
Sub-Investigator: Xavier MOISSET         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03152305     History of Changes
Other Study ID Numbers: CHU-331
2014-A00042-45 ( Other Identifier: 2014-A00042-45 )
Study First Received: May 11, 2017
Last Updated: May 11, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Migraine
Intracranial pressure
Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 25, 2017