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临床试验/NCT06573840
NCT06573840
撤回
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A Functional MRI Study: Assessing Brain Function in Post Stoke Patients

NeuroGlove LLC0 个研究点2024年11月10日

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.)

注册库
clinicaltrials.gov
开始日期
2024年11月10日
结束日期
2024年11月15日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
NeuroGlove LLC
责任方
Sponsor

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.

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