Brain-based Understanding of Individual Language Differences After Stroke

Active, not recruiting

• Conditions: Stroke; Aphasia; Alexia

• Registration Number: NCT04991519
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2028-08-30
• Study Completion: 2028-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Controls:

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)	Collected within 1 month of behavioral testing	Part of MRI sequence that measures deep grey matter structure.
Behavioral testing	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)	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.

Trial Locations

Locations (1)

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States