Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

Study Overview
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Brief Summary
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Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.

Detailed Description
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Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.

Official Title
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Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Diagnostic Test: MMSE, MoCA, functional near-infrared spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35-80 years old Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard) Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA Agree to participate in the clinical trial and sign the informed consent Exclusion Criteria: Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%) Left ventricular ejection fraction < 50% or heart failure Other types of dementia have been diagnosed Severe depression, mental illness, epilepsy Not cooperating with cognitive task evaluation

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MMSE, MoCA, functional near-infrared spectroscopy|MMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cognitive function score | Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function | MMSE score at baseline, 6 months after revascularization. Change of the score is calculated. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameter of evoked cerebral blood oxygenation | Means of HbO detected by functional near-infrared spectroscopy | Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline. | 
| Parameter of evoked cerebral blood oxygenation | Skewness of HbO detected by functional near-infrared spectroscopy | Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline. | 
| Parameter of evoked cerebral blood oxygenation | kurtosis of HbO detected by functional near-infrared spectroscopy | Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,