Neurocognitive and Radiological Assessments in Adult Patients With Moyamoya Disease Undergoing Surgical Revascularization
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment.
研究概览
简要总结
Adult patients with moyamoya disease (MMD) are reported to suffer from considerable impairment of executive function/attention. Although reduced cerebrovascular reserve (CVR) in frontal areas has been detected by perfusion MRI and then confirmed to be associated with executive dysfunction in adult MMD, the structural and functional changes is still unclear with progression of executive dysfunction. Furthermore, it is very important to study the association between the neurocognitive and radiological improvement after surgical revascularization, so as to help detecting cerebral regions which are involved in executive deterioration or improvement after surgery. Then the investigators can determine whether these regions can be used as indicators to decide rational therapeutic schedule and timing of adult MMD with executive dysfunction.
Thus the aim of this study is to primarily find out the neuropsychological and radiological correlates in adult MMD, and then to quantitatively evaluate the effectiveness of surgical revascularization in prevention of executive dysfunction in adult MMD.
详细描述
Previous studies of adult moyamoya disease (MMD) have revealed that vascular cognitive impairment (VCI) is the consequence of ischemic damage to dynamic factors such as cerebral hypoperfusion, rather than to cerebral gray matter. However, it is still unclear which regions are affected by MMD and how these regions respond to the progressive cognitive decline. In other way, the investigators need to detect spatial patterns in the brain activity of MMD in order to understand its pathophysiological nature.
Surgical revascularization has been accepted as the only effective form of treatment in preventing future ischemic episodes. However, its effectiveness in cognitive protection is still unknown. Thus, the investigators determine to quantitatively evaluate cognitive and radiological outcomes in adult MMD postoperatively and during follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed Chinese people aged over 18 years
- •No evidence of recent or remote infarct in the cerebral cortical, basal ganglia, brainstem or cerebellum
- •No evidence of recent or remote intracerebral hemorrhage
- •Diagnosis confirmed by digital subtraction angiography (DSA) according to Suzuki scale
- •No surgical intervention before recruitment
- •Physically capable of cognitive testing
- •Geographically accessible and reliable for follow-up.
排除标准
- •Significant neurological diseases or psychiatric disorders that could affect cognition
- •Other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia
- •Concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention
- •Severe systemic diseases
- •Pregnant or perinatal stage women
- •Any diseases likely to death within 2 yeas
- •Taking drugs such as benzodiazepine clonazepam
- •Any contraindications or allergy to aspirin
- •Allergy to iodine or radiographic contrast media
- •Past history of surgical revascularization
- •Concurrent participation in any other experimental treatment trial
- •Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate.
研究组 & 干预措施
surgical revascularization
Patients will be assigned to either surgical or conservative treatment depending on their clinical symptoms and radiological assessment.
干预措施: Surgical Revascularization (Procedure)
conservative treatment
Normal conservative treatment without surgical intervention.
干预措施: Conservative treatment (Other)
结局指标
主要结局
Neurocognitive outcomes at 3/6/12/24-month follow-up after surgical revascularization or conservative treatment.
时间窗: 2 years
Measure neurocognitive outcomes with a battery of neuropsychological tests covering global cognition, executive, memory, language, and visuospatial functions. It involves the Mini-mental state examination (MMSE), the Memory and Executive Screening test (MES), the Trail Making Test (TMT), the Auditory Verbal Learning Test (AVLT), the verbal fluency test (VFT), the Rey-Osterrieth complex figure test (CFT), etc.
次要结局
- The number of participants who suffer from all stroke or death during 30 days to 24 months(24 months)
- The changes from baseline in single photon emission computed tomography (SPECT).(2 years)
- The changes from baseline in blood oxygen level-dependent functional magnetic resonance imaging (BOLD fMRI) during rest.(2 years)
- Postoperative neurocognitive outcomes before discharge.(average of 1 week after surgery)
- The number of participants who suffer from all kinds of adverse events related to surgery.(30 days)
- The changes from baseline in modified Rankin scale (mRS) and national institutes of health stroke scale (NIHSS).(at 7 days, 30 days, 3/6/12/24 months)
- Postoperative radiological outcomes before discharge.(average of 1 week after surgery)