- Measurement of the flow response to dermal application of capsaicin in the trigeminal nerve region in women with and without migraine.- Measurement of the flow response to dermal application of capsaicin in the trigeminal nerve region at various…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in capsaicin-induced vasodilatation between women with and without
migraine.
Effect of estrogen en progesterone levels on the capsaicin induced
vasodilatation.
Secondary outcome
not applicable
Background summary
Migraine is a chronic and debilitating neurovascular disorder. It is associated
with unilateral headache attacks with dysfunction of the autonomic nervous
system and is sometimes preceded by an aura. It is a condition that affects
more women than men (prevalence: women 17% and men 6%). Reproductive
milestones as menarche, pregnancy and menopause in women are associated with
changes in attack intensity and frequency. This suggests a connection between
fluctuations in estrogen levels and the occurrence of migraine attacks.
Menstrual migraine, a condition in which the attacks occur primarily around the
perimenstrual days, also gives strong indication for involvement of estrogen
fluctuations in migraine.
The pathofysiology of migraine is still unclear. It is often assumed that
vasodilatation of intra-and extracranial vessels responsible for pain during
attacks. The transient receptor potential vanilloid type 1 (TRPV1) receptors on
the nerve endings of the trigeminal tract appear to have a key role in the
attacks. Stimulation of the TRPV1 receptor consequences in release of CGRP
(calcitonin gene-related peptide). CGRP is a neuropeptide with vasodilatory
effect. We think that changes in estrogen levels affect the sensitivity of the
TRPV1 receptor and consequently the release of CGRP. With our research we aim
to improve our understanding of this process. The TRPV1 receptors in the skin
nerves of the forehead can be stimulated by local application of capsaicin.
Capsaicin is the pungent ingredient of chili peppers and is locally used as an
analgesic for neuropathic pain and itching. Stimulation of the TRPV1-receptor
leads via release of CGRP to cutaneous vasodilatation. Maximal TRPV1-receptor
stimulation should be desired. With a laser Doppler flow scan the degree of
vasodilatation can be measured. With a saliva test we measure the CGRP
concentration in saliva.
Postocclusive reactive hyperaemia (PRH) is a methode used to assess
microvascular function. PRH is the rapid increase in blood flow after the
release of an arterial occlusion. In this study we want to assess any relation
between the dermal flow response to capsaicin and the PRH.
Study objective
- Measurement of the flow response to dermal application of capsaicin in the
trigeminal nerve region in women with and without migraine.
- Measurement of the flow response to dermal application of capsaicin in the
trigeminal nerve region at various estrogen levels.
- Determining if the flow dermal response to capsaicin is related to the
maximal dermal flow response during reactive hyperaemia.
Study design
From three hours before the test, test-subjects are not allowed to consume
coffee, tea or any other caffeinated beverages. From three hours before the
test, test-subjects are not allowed to eat and from two hours before the test
any physically strenuous activities are prohibited.
The capsaicin test will be preformed while the test-subjects rests supine on a
bed. Three small rubber electrodes containing a 0.5ml reservoir will be placed
on the forehead and subsequently filled with two capsaicin solutions (0.2 mM
and 20 mM) and saline. One electrode will be placed in the neck region. After a
baseline measurement of the blood flow for two minutes, a small current will
be run through the electrode with saline 5 times. The duration of the current
will be 1 minute each time. The blood flow is then measured for an additional
30 minutes.The dermal blood flow will be measured with the PeriScan PIM 3
system.
With a saliva test we measure the CGRP concentration in saliva. Participants
will have to chew on a cotton swab during 5 minutes.
A blood pressure cuff is then placed on the upper non-dominant arm to measure
the Postocclusive reactive hyperaemia (PRH). For this part of the experiment
the dermal flow is measured at the volar site of the forearm. The pressure in
the forearm cuff is quickly increased to 200 mmHg. This pressure is maintained
for five minutes. Then the pressure in the cuff is quickly released and the PRH
is continuously measured for ten minutes with the PeriScan PIM 3 system.
After the test two vials of blood will be taken for the determination of the
estrogen and progesterone levels and DNA research. The total research time will
be 50-70 minutes.
Study burden and risks
The amount of time consumed by this research is the only burden. There are no
risks associated with this research. Capsaicin application can cause temporary
redness and some irritation of the skin.
's Gravendijkwal 230
3015CE Rotterdam
NL
's Gravendijkwal 230
3015CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
General Inclusion criteria:
• Women
• Age between 18 and 75 years
• Non-smoking for > 6 months
• Body mass index between 18 and 30
• Capable and willing to give informed consent
• General good health, based on medical history and physical examination;Subjects with migraine:
• Should have diagnosed migraine, fulfilling criteria 1.1. Migraine without aura of International Classification of Headache Disorders (ICHD).
• Migraine attacks should occur exclusively on day 1±2 (ie, days -2 to +3) of menstruation in at least two out of three menstrual cycles and additionally at other times of the cycle.
• Should have a natural and regular menstrual cycle
• Age between 18 and 45 years;Subjects without migraine:
• Should have a natural and regular menstrual cycle
• Age between 18 and 45 years
Postmenopausal subjects
• Should be amenorrhoeic for at least 1 year
Exclusion criteria
• Use of hormonal contraceptives or hormonal replacement therapy
• History of cardiovascular disease
• Any serious illness that can compromise study participation
• Regular use of medication outside the period of migraine attacks
• Dermal diseases at the upper frontal side of the face
• Pregnancy or breastfeeding
• History of sensitivity to the fruits of capsicum plants (eg chilli peppers)
• Alcohol or drug abuse
Design
Recruitment
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 | NL33804.078.10 |