Intracranial pressure variability in migraine; A prospective study to evaluate changes in intracranial pressure during different migraine attack phases

Completed

Conditions: Headache
migraine
10019231

Registration Number: NL-OMON35939

Lead Sponsor: eurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Inclusion criteria; i) age between 18-60 years; ii) provided written informed consent; iii) BMI 18.5-30 kg/m2

Exclusion Criteria

Exclusion criteria; i) (history of) severe otological disease possibly influencing measurements (e.g. Morbus Menière; hearing loss); ii) patients with a pacemaker and/or deep brain stimulation.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>ICP measurements<br /><br>- The instrument to be used in the proposed study measures DPOAEs and CM<br /><br>continuously. From these measurements, phase<br /><br>shifts of DPOAEs and CM (expressed in degrees) can be<br /><br>recorded. These phase shifts are correlated to a certain change in ICP,<br /><br>expressed in daPa/ cm H2O[37].<br /><br><br /><br>Clinical symptoms;<br /><br>- Scoring of migraine attack phase according to the IHS criteria[3];<br /><br>- Presence of premonitory symptoms (yawning, irritability, food cravings,<br /><br>fluid retention, depression, irritation, hyperactivation, hypersensitivity,<br /><br>dysphasia, anorexia, nausea and vertigo);<br /><br>- Nature of headache symptoms (severity, character, sidedness, aggravation with<br /><br>physical activity);<br /><br>- Presence of migraine associated symptoms (nausea, vomiting, photophobia,<br /><br>phonophobia); </p><br>

Secondary Outcome Measures