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Clinical Trials/NCT04991519
NCT04991519
Active, not recruiting
Not Applicable

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

Georgetown University1 site in 1 country400 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia
Sponsor
Georgetown University
Enrollment
400
Locations
1
Primary Endpoint
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
August 30, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)

Time Frame: Collected within 1 month of behavioral testing

Part of MRI sequence that measures deep grey matter structure.

Behavioral testing

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

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