We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intracranial Pressure During Migraine (MigICP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152305
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Menstrual Migraine Other: Intracranial pressure variations

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 Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Measure of Intracranial Pressure Variations During Migraine Attacks
Actual Study Start Date : July 21, 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 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