G43.1 G43.0
Conditions
Interventions
Group 1: Patients with episodic migraine with aura
For this monocentric case-control study, participants of the 3 groups (migraine with aura, migraine without aura, and healthy control subjects) will
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Patients: - episodic migraine with or without aura according to ICHD-3 criteria - existing health insurance Healthy control subjects: Individuals without a diagnosis of migraine according to ICHD3 criteria who meet the exclusion criteria below. Control subjects will be recruited matched for age and gender of patients.
Exclusion criteria
Exclusion criteria: - other headache disorder according to ICHD-3 criteria except episodic tension headache (2 antihypertensive drugs), body mass index 30 kg/m2 - pregnancy - severe psychiatric illness, addicition to alcohol or drugs - other medical condition that, in the opinion of the study physician after evaluation of benefit and risk, is not compatible with study participation. - drugs: statins, anticoagulants, triptan therapy (<24h). - contraindication for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the level of endothelial microvesicles compared between migraine patients with different severities of WMH. Microvesicles will be determined by FACS analysis from peripheral venous blood obtained on the day of the MRI scan (one single study visit). The primary hypothesis is that endothelial biomarkers are associated with the presence of and severity of WMH in migraine patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary endpoints are: Comparing patients with migraine with aura, migraine without aura, and healthy controls, and according to gender and age: (a) Levels of blood-based endothelial biomarkers (including endothelial microvesicles, endothelial autoantibodies, hs-CRP, mCRP, E-selectin, P-selectin, VCAM, ICAM, vWF antigen and activity). (b) Presence and extent of WMH (3T MRI 3D FLAIR, Wahlund score and semi-automated quantification). (c) Presence and extent of structural white/gray matter changes (3T MRI diffusion tensor imaging, voxel-based morphometry). d) Markers of arterial vascular stiffness (aortic augmentation index, carotid-femoral pulse wave velocity using SphygmoCor XCEL). e) markers of peripheral endothelial function (reactive hyperemia index using EndoPAT2000) as well as the association of these variables with each other. Additional exploratory endpoints include: (f) presence and level of emotional stress (PSS-10, perceived stress scale and DASS, Depression Anxiety Stress Scale). (g) levels of sex hormones (estradiol, progesterone, testosterone) h) levels of neurodegenerative markers (t-tau, NFL, GFAP and UCH-L) and their association with the abovementioned markers of endothelial dysfunction in patients with migraine with aura, migraine without aura and healthy controls, and according to gender and age. | — |
Countries
Germany
Contacts
Public ContactKristin Sophie Lange
Charité - Universitätsmedizin Berlin, Klinik für Neurologie
Outcome results
None listed