Topiramate and Cerebrovascular Response in Migraineurs

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.

Official Title
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Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 to 65 years newly-diagnosed patients with migraine without aura (International Headache Society classification) symptom frequency (at least 2 episodes of migraine attack/month) Exclusion Criteria: prior use of preventive medication patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking) patients who take antihypertensive agent or antidepressant patients who were pregnant, breast-feeding or actively smoking patients with neurological or cerebrovascular diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topiramate<br>topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks | Drug: Topiramate<br>* topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Cerebrovascular reactivity | Transcranial Doppler sonography (TCD) was performed twice in migraineurs before and after the topiramate treatment during their interictal period of headache. Measurements: the mean flow velocity (MFV) of the right middle cerebral artery (MCA) and the left posterior cerebral artery (PCA). After 1 minute of adaptation period to the darkness, flashlights of 10 Hz were presented using a light source of an electroencephalography machine (PS40/R-220, Grass Technologies, West Warwick, USA). Recordings were performed for 10 cycles, and each cycle consisted of 10-second stimulation-on and 10-second stimulation-off. Calculation: Cerebrovascular reactivity (CVR) CVR = Δ V/Vb or Δ V/(VbxΔT) Where Vb is the baseline MFV, Δ V/Vb is the percentage MFV increase (amplitude), ΔT is the time from the onset of the stimulation to the peak MFV, and Δ V/(VbxΔT) is the slope of the MFV increase. | between baseline and after 2-month treatment of topiramate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the mean flow velocities in the middle and posterior cerebral artery | Measurements: Same as outcome 1. | between baseline and after 2-month treatment of topiramate |