The primary objective is to validate the LSCI against the LDPI in the assessment of the forehead DBF induced by capsaicin application and saline iontophoresis.
ID
Source
Brief title
Condition
- Headaches
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The maximal DBF value (Emax) in response to capsaicin and electrical
stimulation will be calculated for every participant.
Secondary outcome
The association of hormone levels and oxytocin levels with DBF measurements,
considering their possible interactions with the CGRP system.
Background summary
The dermatome of the forehead is innervated by the trigeminal nerve, and is
therefore, suitable to investigate trigeminal nerve-related mechanisms. The
implication of these mechanisms is especially relevant in the neurovascular
chronic condition migraine. Indeed, the human forehead has been used in a
trigeminal nerve-mediated vasodilation model to study vascular aspects of
migraine. The studies up to date have used Laser Doppler Perfusion Imager
(LDPI) to assess the forehead dermal blood flow (DBF) which is indicative for
the trigeminovascular activity. Alternatively, skin blood perfusion changes can
be investigated using a newer device, the Laser Speckle Contrast Imager (LSCI),
which provides real-time DBF measurements with a higher resolution. Both
techniques are currently being used to measure and validate the microvascular
function using DBF changes of the forearm. Nevertheless, the evidence in the
context of forehead blood flow assessment is missing. Thus, the goal of the
VALIDATION-study is to validate the use of LSCI by assessing its agreement and
reproducibility with LDPI using the forehead model in healthy women. This is a
first step before the forehead model using the LSCI can be applied to migraine
patients.
Study objective
The primary objective is to validate the LSCI against the LDPI in the
assessment of the forehead DBF induced by capsaicin application and saline
iontophoresis.
Study design
This is a cross-sectional observational study with non-invasive measurements.
Study burden and risks
Risks of LDPI/LSCI: none documented. Risks of venipuncture for blood
withdrawal: mild pain and bruising. It is possible that mild discomfort will be
experienced during inflation of blood pressure cuff (but this is similar to the
discomfort experienced at for example the GP, in case of blood pressure
measurements).
The burden for participants will consist of approximately 255 minutes of a
single visit (including preparation time) and will be requested to complete a
questionnaire.
Participation does not hold health related benefits for the participants, but
participants will be offered a financial compensation.
Wytemaweg 80
Rotterdam 3015 CE
NL
Wytemaweg 80
Rotterdam 3015 CE
NL
Listed location countries
Age
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
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 <48 hours prior to the study visit;
• Current use of any drugs as primary or secondary prevention of cardiovascular
disease and current use of any hormonal substances;
• 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,
tranquilizers, 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 the
forehead that might interfere with the measurements;
• History of sensitivity to the fruits of capsicum plants (e.g. chili peppers);
• Any COVID-19 related symptoms on the day of inclusion.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81666.078.22 |