A Longitudinal Study of Motor Control and Brain Images in Patients With Brain Damage: Clinical Measures and Multimodel Imaging Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline of fMRI analysis in 6 months and 12 months
研究概览
简要总结
The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in Cerebral palsy (CP) and stroke patients.
详细描述
Brain damage may lead to various motor deficits, which further influence the activities and participation. Cerebral palsy (CP) and cerebral vascular accident (CVA) are the common disorder for congenital and acquired brain damage, respectively. It would be ideal to characterize neural network in patients with brain damage that underlies their clinical behavior by identifying altered neural network associated with behavioral improvement.
The investigators hypothesize that the level of motor control and impact of brain image will change with time in patients with brain damage. Under this hypothesis, the measures of motor control are correlated with neural changes reflected by imaged using structural MRI, resting state fcMRI, and active fMRI sequences. The aim of this study is to investigate the motor control and brain image in patients with brain damage evaluated by clinical measures and multimodel imaging studies such as structural MRI, resting state fcMRI, and active fMRI. The primary goal of this study is to establish and evaluate an image-based biomarker for the impaired motor control and sensory information processing present in CP and stroke patients. This study will be executed in 3 years: 1st phase: to establish the multimodal brain images and motor control in healthy subjects; 2nd phase: to establish the brain images and motor control in patients with stroke.; and 3rd phase: to establish the brain images and motor control in patients with CP. Additionally, the association between brain images and clinical changes involving movement and participation will be analyzed. The investigators will identify the predictors influencing final outcome and analyze. The differences in structural image, functional connectivity and brain activation between patients with brain damage and healthy controls can potentially be a bio-marker for prognosis. The investigators believe the results of this study will allow clinicians to understand the brain mechanisms underling motor control and early predict the outcome for patients with brain damage.
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
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CP-patients with CP and aged 6-18 years
- •CVA-patients with stroke and aged 40-75 years
排除标准
- •contraindication to MRI
- •history of psychiatric disease
- •received BTX-A injection or surgery in recent six months
- •severe psychological impairments, such as mental retardation, autism or severe communication problems
- •progressive disorders, such as neurodegenerative disease
- •active medical disease, such as infection
结局指标
主要结局
Change from baseline of fMRI analysis in 6 months and 12 months
时间窗: baseline, 6 months, 12 months
fcMRI at resting, active-task fMRI. DTI
次要结局
- Change from baseline of movement and participation for stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of kinematic analysis in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of severity for stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of severity for CP patients in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of Quality of life in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of movement and participation for Healthy adults and stroke patients in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of movement and participation for Healthy children and CP in 6 months and 12 months(baseline, 6 months, 12 months)
- Change from baseline of movement and participation for CP in 6 months and 12 months(baseline, 6 months, 12 months)