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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35781

Enrollment

Registered

2011-07-14

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

migraine

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results