Predictors of Parkinson's Disease Progression in Sample of Egyptian Patients; Clinical and Biochemical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- predictors of progression of motor features of PD
研究概览
简要总结
it is a prospective longitudinal observational study, aiming to to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients. it measures the baseline motor, non-motor, biochemical and imaging characteristics at enrollment and its relation to PD progression over 3 years
详细描述
it is a prospective longitudinal observational study, aiming to to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients. it measures the baseline motor, non-motor, biochemical and imaging characteristics at enrollment and its relation to PD progression over 3 years.
The aim of this study is to identify clinical, and biochemical baseline predictors of motor and non-motor PD progression in sample of Egyptian patients.
Methods:
Assessment:-
Time • During the 2 years recruitment of patients from 2019 to 2021, the assessment will be at base line (first clinic visit), after 1yr, and after 2yrs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• All are Arabic-speaking individuals diagnosed with PD by a movement disorder neurologist based on the UK bank criteria for idiopathic Parkinson's disease.
- •An oral informed consent will be taken from the cases before they participate in the study.
排除标准
- •Patients with red flag for being diagnosed with IPD and indicating secondary eg: vascular, Neuroleptics or atypical parkinsonism , progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration syndrome, Lewy body dementia
- •Patients with with other comorbid chronic diseases
- •PD patients who refused or could not complete questionnaires.
结局指标
主要结局
predictors of progression of motor features of PD
时间窗: at 1, 2,3 years follow ups
change in MDS UPDRS, Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS), from 0 to 260. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living (13 questions) total is from 0 to 52; II: Motor Experiences of Daily Living (13 questions, from 0 to 52) III: Motor Examination (20 questions), total is from 0 to 132; IV: Motor Complications (6 questions, from 0 to 24). In each question: 0=normal; 1=slight; 2= mild; 3=moderate; 4=severe.higher values represent a worse outcome
predictors of progression of non motor features of PD
时间窗: at 1, 2 ,3 years follow-ups
changes in Nonmotor, and depression scores. Non-Motor Symptom assessment scale for Parkinson's Disease, Symptoms assessed over the last month. Each symptom scored with respect to: Severity: from 0 to 3 Frequency: from 1 to 4 Yes/ No answers are not included. score of each question = frequency x severity . There are nine domains: Cardiovascular including falls, Sleep/fatigue, Mood/cognition, Perceptual problems/hallucinations, Attention/memory, Gastrointestinal tract, Urinary, Sexual function, and Miscellaneous. Higher values represent worse outcome. Depression assessment scales: Beck depression inventory (BDI) (Higher values represent worse outcome, Arabic version)
次要结局
- development of drug (levodopa) complications(at 1,2, and 3 years)
- development of gait problems(at1,2, and 3 years)
- change of quality of life(at 1, 2 ,3 years)
研究者
Ali Shalash
professor
Ain Shams University