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Relationships between cerebrovascular function and the incidence and severity of headache in premenopausal women

Relationships between cerebrovascular function and the incidence and severity of headache in premenopausal women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001230246
Acronym
MM2018
Enrollment
79
Registered
2018-07-23
Start date
2018-08-23
Completion date
2019-12-18
Last updated
2020-11-09

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

Conditions

None listed

Brief summary

Migraine is an episodic primary headache disorder, affecting 10% of adults with varying degree of disability that can interfere with daily living. The prevalence of migraine is 2 to 3 times greater in women than in men, particularly during reproductive years; peaking between 30 and 39 years of age and a second peak around 50 years old (onset of menopause). It is estimated that migraine attacks related to menstruation occur in 35-51% of women and are associated with the fall of estrogen levels (~2 days before menses) and may continue for a few more days until estrogen levels rise again. There is growing appreciation of the link between migraine and heightened risk of vascular diseases, particularly for stroke. In fact, studies have shown that women with migraine, especially with aura, are at twice the risk for ischemic stroke. We want to characterise any circulatory abnormalities in the brain in women who suffer from menstrual migraine. In this study, we will measure the flow of blood in the brain in premenopausal women and compare those who suffer from menstrual migraine with those who are not susceptible. We will also explore the role of blood pressure, differences in gene expression, stiffness of blood vessels, and the effects of menstrual migraine on quality of life and mental performance. We aim to see whether abnormalities of blood flow in the brain may predispose women to menstrual migraine and to see whether these abnormalities are associated with differences in gene expression between those who suffer from menstrual migraine and those who are not susceptible. This information will help us to design more effective interventions to counteract migraine.

Interventions

70 premenopausal women will be allocated to either the menstrual migraine group or the control group. They will attend our clinic for one visit only. We will measure blood pressure and arterial compliance, then fit a headpiece with transcranial doppler (TCD) ultrasound probes to measure blood flow in the brain; this will be monitored while participants perform a hypercapnia test and the N-back test. Participants will complete three questionnaires (MIDAS, HIT-6 and MS-QOL). A blood sample will be

70 premenopausal women will be allocated to either the menstrual migraine group or the control group. They will attend our clinic for one visit only. We will measure blood pressure and arterial compliance, then fit a headpiece with transcranial doppler (TCD) ultrasound probes to measure blood flow in the brain; this will be monitored while participants perform a hypercapnia test and the N-back test. Participants will complete three questionnaires (MIDAS, HIT-6 and MS-QOL). A blood sample will be obtained to explore gene expression. The visit will take approximately two and a half hours. Women will be included in the menstrual migraine group if they suffer from migraine/headache +/- 3 days from their period and/or ovulation (mid-cycle) in the previous three menstrual cycles, lasting 4-72 hours with at least two of these characteristics: unilateral location, pulsating or throbbing pain, pain of at least moderate intensity, or aggravated by or causing avoidance of physical activity (walking/stair climbing). They should be free from headache attacks at other times of the cycle.

Sponsors

University of Newcastle
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Women between age 25 and menopause (> 6 months cessation of menses) Blood pressure <160/100mmHg (determined at screening visit) For migraine group: Suffer from migraine/headache +/- 3 days from their period and/or ovulation (mid-cycle) in the previous three menstrual cycles, lasting 4-72 hours with at least two of these characteristics: unilateral location, pulsating or throbbing pain, pain of at least moderate intensity, or aggravated by or causing avoidance of physical activity (walking/ stair climbing). They should be free from headache attacks at other times of the cycle.

Exclusion criteria

Not fluent in reading and writing in English. No detectable transcranial Doppler (TCD) ultrasound signal in the middle cerebral artery on either side. TCD blood flow velocity >185 cm/s Liver or kidney disease Hysterectomy Malignant cancer Insulin-dependent diabetes Fibromyalgia Excessive alcohol intake (>15 drinks per week) Pregnancy or breastfeeding Major depression Neurological conditions including stroke, TIA, major depression, multiple sclerosis, epilepsy, Chiari malformation, Parkinson’s disease or dementia or mild cognitive impairment. Unwilling to provide a blood sample Smoker History of using Botulinum toxin or neuromodulation devices for treatment of headaches.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 15, 2026