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

Not Applicable

Completed

• Conditions: Migraine; Neurological - Studies of the normal brain and nervous system; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001230246
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-23
• Study Completion: 2019-12-18
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 79

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebrovascular responsiveness (CVR) to a hypercapnic stimulus, assessed with TCD ultrasound[Week 0, 1 visit only.]

Secondary Outcome Measures

Name	Time	Method
Composite Secondary Outcome: Clinic systolic blood pressure (BP), diastolic BP, heart rate (HR), large and small artery elasticity indices, assessed using a Cardiovascular Profiler.[Week 0, 1 visit only.];Composite Secondary Outcome: Pulsatility and resistive indexes and resistance in the anterior cerebral circulation, assessed with a cardiovascular profiler and TCD ultrasound.[Week 0, 1 visit only.];Cognitive performance on the N-back test (administered on an iPad).[Week 0, 1 visit only.];Cerebral blood flow velocity changes during cognitive testing (CVR to cognitive stimuli), assessed with TCD ultrasound.[Week 0, 1 visit only.];5-item Migraine Disability Assessment Questionnaire (MIDAS).[Week 0, 1 visit only.];6-item Headache Impact Test (HIT-6).[Week 0, 1 visit only.];Migraine Specific Quality of Life Questionnaire MS-QOL (version 2.1).[Week 0, 1 visit only.];Gene expression, assessed by polymerase chain reaction (PCR); this is an exploratory outcome.[Week 0, 1 visit only.]