Intracranial Pressure During Migraine (MigICP)

May 11, 2017 updated by: University Hospital, Clermont-Ferrand

Measure of Intracranial Pressure Variations During Migraine Attacks

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during menstrual migraine attacks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during menstrual migraine attacks
Relationships between ICP variations and pain relief
Time Frame: during menstrual migraine attacks
during menstrual migraine attacks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-331
  • 2014-A00042-45 (Other Identifier: 2014-A00042-45)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menstrual Migraine

Clinical Trials on Intracranial pressure variations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe