The Clinical and Neuroimaging Differences Between Patients With Vascular Parkinsonism and Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Frontal Assessment Battery scale.
研究概览
简要总结
Vascular parkinsonism (VP) is defined as the presence of parkinsonian syndrome, evidence of cerebrovascular disease by brain imaging and an established relationship between the two disorders.
However, the diagnosis of VP is problematic. This study aims to distinguish VP from Parkinson's disease (PD) in multiple aspects including clinical features as motor ,non motor symptoms
,response to treatment ,cognitive assessments by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and transcranial color-coded duplex (TCCD) findings. This differentiation will have therapeutic and prognostic implications .
详细描述
Type of Study : case -control comparative study.
• Study Setting: Patients with VP and patients with PD from movement disorders and stroke outpatient clinics in Ain shams University Hospitals.
Sampling Method study of consecutive patients in Ain Shams University clinic, who had been regularly followed up in the clinic and already had a diagnosis either VP or PD at the time of data collection.
Sample Size: 30 patients diagnosed as VP, 50 patients diagnosed as PD, and 30 healthy age and sex matched controls. The difference in selected quantitative variables used to evaluate the participants is used to estimate the sample size.
This study aims to distinguish VP from Parkinson's disease(PD) in multiple aspects including clinical features as motor ,non-motor symptoms, response to treatment ,cognitive assessments by using multiple scales, neuro-radiological features of magnetic resonance imaging (MRI) and transcranial color-coded duplex(TCCD)findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with PD or VP, and healthy controls will be included in the study.
- •PD diagnosis will be based on the Queen Square Brain Bank for Neurological Disorders clinical criteria and MDS criteria.
- •The VP patients will be included if they fulfill the following criteria (Zijlman's diagnostic criteria)Parkinsonism presentation (at least two of the cardinal features: tremors, bradykinesia, rigidity and postural instability).
- •Cerebrovascular disease, defined as evidence of relevant cerebrovascular disease by brain imaging or the presence of focal signs or symptoms consistent with stroke.
- •A relationship between (1) and (2): acute or delayed progressive onset of parkinsonism.
- •Based on the above criteria, two forms of VP are suggested: one with acute onset, and another one with insidious progression. The diagnosis will be confirmed by assigning a vascular score. Two points or more are essential to diagnose VP. The points will be assigned as follows:
- •Two points: Pathologically or angiographically proven diffuse vascular disease.
- •One point: Onset of parkinsonism within 1 month of clinical stroke.
- •One point: History of two or more strokes.
- •One point: Neuroimaging evidence of vascular disease in two or more vascular territories.
- •One point: History of two or more risk factors for stroke (hypertension, smoking, diabetes mellitus, hyperlipidaemia, presence of heart disease associated with stroke [coronary artery disease, atrial fibrillation, congestive heart failure, valvular heart disease, mitral valve prolapse, and other arrhythmias], family history of stroke, history of gout, and peripheral vascular disease)
排除标准
- •PD patients with age at onset less than 40 years.
- •Any alternative cause that significantly impair gait.
- •Inability of the patient to undergo neuroimaging.
- •Patients couldn't perform the test or severely demented.
- •Atypical and other secondary parkinsonism as patients who had a history of toxin exposure.or antipsychotic drugs treatment by history ,neurological examination and brain MRI .
- •Family or patient's refusal to give written consent.
结局指标
主要结局
Frontal Assessment Battery scale.
时间窗: 2 year ....will be at single point
Frontal Assessment Battery scale..total score is from a maximum of 18, higher scores indicating better performance.
MDS-UPDRS scale on on and off state
时间窗: 2 year... will be at single point
It detects the motor differences between Vascular Parkinsonism and Parkinson's Disease by scores on the scale ...the maxium score is 199 represents the worst (total disability) with a score of zero representing (no disability)
Montreal Cognitive Assessment (MoCA) (Arabic version)
时间窗: 2 years....will be at single point
MoCA scores range between 0 and 30. .high score more than or equal 26 is normal
Non motor symptoms scale
时间窗: 2 years.....will be at single point
It detects the non motor symptoms differences between Vascular Parkinsonism and Parkinson's Disease byUsing a distribution of NMSS scores by quartiles, a classification based on levels from 0 (no NMS at all) to 4 (very severe NMS) for 30 itemes ...high score is worst
White matter severity by MRI brain
时间窗: 2 years....will be at single point
White matter differences by fazekas scale 0,1,2 or 3 scores
Addenbrooke's test (Arabic version)
时间窗: 2 year ....will be at single point
for aassement of Visuospatial skills, Language and verbal fluency result score 16 for visuospatial processing ,26 for language 14 for fluency high score is best
Wechsler Adult Intelligence Scale (WAIS)
时间窗: 2 year....will be at single point
The average score for the test is 100, and any score from 90 to 109 is considered to be in the average intelligence range. Score from 110 to 119 are considered to be High Average. Superior scores range from 120 to 129 and anything over 130 is considered Very Superior.
次要结局
- Substantia nigra Echogenicity by transcranial doppler(2 years)
- Carotid arties wall thickness by Extra cranial duplex(2 year)
研究者
Ali Shalash
professor of Neurology
Ain Shams University