A Functional MRI Study: Assessing Brain Function in Post Stoke Patients
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Ischemic Stroke
- 发起方
- NeuroGlove LLC
- 主要终点
- Brain Function
- 状态
- 撤回
- 最后更新
- 去年
概览
简要总结
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort.
详细描述
This is a prospective, single center, observational clinical study containing two cohorts the healthy cohort and post stroke cohort. A total of 13 subjects will be enrolled. Three (3) healthy volunteers will be enrolled in the healthy cohort. Ten (10) subjects who have recently experienced a mild to moderate acute ischemic stroke will be enrolled in the post stroke cohort. Up to13 subjects will be enrolled and complete study procedures. There will be 2 study cohorts enrolled in the study: 1. Healthy Cohort: 3 healthy volunteers (enrolled from the general population) 2. Post Stroke Cohort: 10 subjects who have experienced mild to moderate stroke symptoms that did not completely resolve after acute interventions. (Mild to moderate stroke symptoms is defined as a NIHSS score of 5 to 15.)
研究者
入排标准
入选标准
- 未提供
排除标准
- •Coma, inability to cooperate with the study based on impaired level of consciousness or confusion.
- •Known neurological deficit prior to stroke (including but not limited to previous stroke, MS, Parkinson's disease).
- •Physical limitations of the weak upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.) Any contraindication to the imaging required per the protocol. Complete middle cerebral artery infarction based on imaging. Carotid artery stenosis \>50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment).
- •Subjects has a known history of substance abuse (drug) or alcohol dependence, or lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
- •If female, subject is pregnant at the time of enrollment or planning to become pregnant during the trial period.
- •Subject has any other acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures.
- •Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
结局指标
主要结局
Brain Function
时间窗: 2 hours
Evaluate brain function through a functional MRI (fMRI) in both healthy subjects (without history of stroke) and post stroke patients.