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TrigeminoVAscuLar actIvity using a foreheaD dermAl blood flow model: a validaTION study

TrigeminoVAscuLar actIvity using a foreheaD dermAl blood flow model: a validaTION study - VALIDATION-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53974
Enrollment
20
Registered
2023-02-02
Start date
2023-02-18
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Females aged between 18 and 40 years; • Non-smoking; • Body mass index 18-30 kg/m2; • All females should have a regular menstrual cycle and not using oral contraceptives. Measurements will be performed in the middle of their cycle; • Capable and willing to give written informed consent; • General good health (as specified in the exclusion criteria), based on their (self-reported) medical history.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • A history of migraine or current migraine (including aura without headache), as determined with the official International Criteria of Headache Disorders (version 3); • Medical history or self-reported symptoms of conditions related to (peripheral) vascular disease or any hormonal disorders, e.g. cardio- or cerebrovascular events, peripheral arterial disease, chronic kidney disease, (pre)diabetes mellitus, uncontrolled chronic hypertension, congestive heart failure, hyperlipidaemia, hypercholesterolemia, a history of ischemic stroke, preeclampsia or PCOS, adrenal insufficiency, hyperthyroidism, hypothyroidism, et cetera; • Use of any vasoactive drugs (including nonsteroidal anti-inflammatory drugs (NSAIDs)) for

Design outcomes

Primary

MeasureTime frame
The maximal DBF value (Emax) in response to capsaicin and electrical stimulation will be calculated for every participant.

Secondary

MeasureTime frame
The association of hormone levels and oxytocin levels with DBF measurements, considering their possible interactions with the CGRP system.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)