Trigeminal sensitivity and hormonal fluctuations during the onset of migraine; A biochemical and neurophysiologic study in male migraineurs

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Migraine patients
Inclusion criteria are: i) males; ii) migraine with/ without aura according to the IHS criteria;
ii) baseline attack frequency of 1 to 3 attacks per month; iii) moderate or severe headache
during attacks; iv) age >18 years.;Healthy controls
Healthy volunteers will be age and gender matched.

Exclusion Criteria

Migraineurs:
Exclusion criteria are: i) more than 10 days of headache
per month; ii) inability to differentiate between migraine and other forms of headache; iii)
suffering from only migraine auras/ migraine sans migraine; iv) current use of medication
influencing reproductive hormone levels; v) use of prophylactic anti-migraine medication; vi)
Body Mass Index (BMI) under 20 or above 28; or vii) current smoking (nicotine is known to
increase CGRP release96); viii) frequent consumption of spicy foods; ix) severe arterial
hypertension97; x) intake of high-fat foods directly before measurements (as is suggested to
influence plasma CGRP levels98;99).;Healthy controls
Exclusion criteria are i) personal or
first-degree-relative history of migraine or other primary headache syndrome, except
infrequent episodic tension type headache; ii) headache on >2 days per month; iii) BMI <20
or >28; iv) current use of medication influencing reproductive hormone levels; v) current
smoking96; vi) severe arterial hypertension97; vii) intake of high-fat foods directly before
measurements (as is suggested to influence plasma CGRP levels98;99); viii) frequent consumption of spicy foods

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome measures<br /><br>For the levels of reproductive hormones, we will focus on intra-individual<br /><br>variability in<br /><br>testosterone : oestradiol ratio (T/E) in migraineurs during different phases of<br /><br>the migraine<br /><br>attack, with the log[T/E] as primary outcome additionally, we will compare this<br /><br>intraindividual<br /><br>variability in migraineurs with those in controls. For salivary measurements, we<br /><br>will focus on amount of peptides (milligrams) produced per time period and<br /><br>compare<br /><br>migraineurs with controls, and between different migraine phases. In blink<br /><br>reflex testing, we<br /><br>will compare blink reflex latencies, duration, amplitudes and area under the<br /><br>curve (AUC)<br /><br>between migraineurs and controls, and between different migraine attack phases.</p><br>

Secondary Outcome Measures