Investigating the Changes of the Cognition in Asymptomatic Intracranial Stenosis Patients After 1-Year Standard Medical Treatment Without Stenting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Memory
研究概览
简要总结
To investigate the cognitive decline after standard medical treatment without stenting in Asymptomatic Intracranial Stenosis patients and the underlying neural mechanism by fMRI.
详细描述
All participants underwent a medical evaluation that included routine laboratory studies before and after 1-year standard medical treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests and Magnetic Resonance imaging scan in multimodalities within 7 days after admission and after 1-year when patients received standard medical treatment at the First Affiliated Hospital of AnHui Medical University. participants were randomly allocated to patient group and the control group.There are about 20 patients and 20 healthy controls in this study.
Firstly, a series of neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, VFT), memory (CAVLT), emotion (HAMA-17,HAMD-14), behavioral and psychological symptoms(NPI). All the tests are conducted in two days. The patients had receiving a magnetic resonance imaging scan in multi-modalities.
After 1-year standard medical treatment,the patients participants were interviewed to obtain the same assessment and magnetic resonance imaging scan in multi-modalities as before. Patients are instructed to focus their answers on the past 15 days. The clinical symptom of participants were followed 6 and 12 months after the admission. Afterwards, they were unblinded by the study coordinator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA).
- •The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).
排除标准
- •History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
- •Organic brain defects on T1 or T2 images.
- •Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- •Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.
研究组 & 干预措施
Patient Group
Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting
干预措施: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin (Drug)
结局指标
主要结局
Changes in Memory
时间窗: baseline, 1-year after medical treatment
The changes in Memory function will constitute the major research outcome measure used to assess response to standard medical treatment.
次要结局
- changes in Montreal Cognitive Assessment (MoCA)(baseline, 1-year after medical treatment)
- DST (Digital Span Test; Forward and Backward)(baseline, 1-year after medical treatment)
- MRI measures(baseline, 1-year after medical treatment)
- The changes in MMSE(Mini Mental State Examination)(baseline, 1-year after medical treatment)
- HAMD (Hamilton Depression Scale)(baseline, 1-year after medical treatment)
- HAMA (Hamilton Anxiety Scale)(baseline, 1-year after medical treatment)
- TMT (Trail Making Test)(baseline, 1-year after medical treatment)
- The Stroop color test(baseline, 1-year after medical treatment)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University