跳至主要内容
临床试验/NCT04991519
NCT04991519进行中(未招募)不适用

Understanding the Brain Basis of Language and Cognitive Functions Through the Study of Individuals With Brain Injury and Healthy Controls

Georgetown University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)

研究概览

简要总结

Strokes often cause a loss of communication ability, referred to as aphasia, as well as cognitive difficulties. Each stroke survivor has a unique pattern of strengths and weaknesses in communication and cognition, and a unique course of recovery. The BUILD study aims to understand the brain basis of these individual differences in stroke outcome. Participants with stroke as well as controls matched in age, educational background, race, and sex are examined using a combination of standardized and in-house tests of language and cognition to provide a detailed profile of strengths and weaknesses. Each participant will have between three and six sessions, including an MRI to measure details of the structure, function, and connections in the brain. The data are analyzed to test how patterns in the stroke lesion explain the patterns of communication and cognitive difficulties, and how patterns in the uninjured parts of the brain explain resilience and recovery from the stroke. Ultimately, we hope that BUILD will guide us toward new targets for brain stimulation treatments or other biologically based treatments that improve language and cognitive abilities after stroke.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Stroke Survivors:
  • Age >=18
  • Stroke in left hemisphere of brain with or without aphasia, or stroke elsewhere causing aphasia
  • Learned English at 8 years or younger
  • Age >=18
  • No history of brain injury resulting from stroke, trauma, infection (i.e. encephalitis), or tumor
  • Learned English at 8 years or younger

排除标准

  • History of other brain conditions that could impact interpretation of results (such as multiple sclerosis, premorbid dementia)
  • Severe psychiatric condition that would interfere with participation in the study
  • History of a learning disability that could impact interpretation of results
  • Additional Exclusion Criteria for MRIs:
  • Pacemaker or magnetic metal in the body that is not MRI compatible
  • Pregnancy
  • Claustrophobia

结局指标

主要结局

MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)

时间窗: Collected within 1 month of behavioral testing

Part of MRI sequence that measures deep grey matter structure.

Behavioral testing

时间窗: Collected within 1 month of MRI

Battery of standard clinical and in-house behavioral tests to measure speech, language, and cognition. Final score is derived from principle components analysis.

DTI (Diffusion Tensor Imaging)

时间窗: Collected within 1 month of behavioral testing

Part of MRI sequence that measures the rate of water diffusion between cells to understand and create a map of internal structures.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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