Migraine
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Women aged 40-60 years without a history of ischemic stroke, preeclampsia and PCOS (i.e. control group, free of comorbidities which have been investigated in our previous multicenter CREW-MIST consortium); - If the participants are still fertile, they should fulfill at least one of the following criteria: o a regular menstrual cycle of 25-30 days as measurements will be performed in the middle of their cycle; o use of oral combination pill and inclusion should not take place in the withdrawal week; o use of Mirena, Kyleena, Liletta, and Skyla (hormonal intrauterine devices) or Nexplanon/Implanon (etonogestrel birth control implant). - Capable and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - A medical history or self-reported symptoms of conditions related to (peripheral) vascular disease, e.g. cardio- or cerebrovascular events, peripheral arterial disease, chronic kidney disease, (pre)diabetes mellitus, uncontrolled chronic hypertension, congestive heart failure, hyperlipidemia, hypercholesterolemia, et cetera; - Current use of any drugs as primary or secondary prevention of cardiovascular disease; - Current or former non-incidental smoking (all substances); - Alcohol consumption of more than seven alcohol units per week; - Current or prior substance dependence/addiction (alcohol, illicit drugs, tranquillizers, narcotics, analgesics); - Current pregnancy; - Insufficient mastery of Dutch or English; - Any other (serious) illnesses that can compromise study participation; - Skin conditions (e.g. psoriasis, eczema, rosacea), scars or tattoos on ventral side of lower arm or digits; - (Any known) allergy for EMLA or L-NMMA; - Any COVID-19 related symptoms (we will perform a screening by phone) on the day of the measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Endothelial function measured as changes in dermal blood flow after Local Thermal Hyperaemia using both the LDPI and LSCI expressed in arbitrary units. The parameters of these LTH measurements will be compared between women with and without migraine under three conditions (control condition, after pretreatment with EMLA and L-NMMA). - Endothelial function measured as Reactive Hyperaemia Index (RHI) using Peripheral Arterial Tonometry (EndoPAT) expressed in arbitrary units. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determining the agreemement and reproducibility of two devices which measure blood perfusion: the Laser Speckle Contrast Imager (LSCI) and the Laser Doppler Perfusion Imager (LDPI). - Blood: hormone levels, lipid profiles, vascular biomarkers, inflammatory parameters and DNA. Other study parameters: - Demographics - Vascular risk factors (hypertension, intoxications, obesity, etc.) - History of disease - Medication use (painkillers, triptan, ergotamine, oral contraception, etc.) - Migraine subtype, attack frequency | — |
Countries
Netherlands
Outcome results
None listed