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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04991519
Other study ID # BUILD
Secondary ID R01DC014960
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date August 30, 2028

Study information

Verified date July 2021
Source Georgetown University
Contact Alycia Laks, MS, CCC-SLP
Phone 202-687-5205
Email al1579@georgetown.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date August 30, 2028
Est. primary completion date August 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (4)

Lead Sponsor Collaborator
Georgetown University Drexel University, MedStar National Rehabilitation Network, National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo) Part of MRI sequence that measures deep grey matter structure. Collected within 1 month of behavioral testing
Primary DTI (Diffusion Tensor Imaging) Part of MRI sequence that measures the rate of water diffusion between cells to understand and create a map of internal structures. Collected within 1 month of behavioral testing
Primary Behavioral testing Battery of standard clinical and in-house behavioral tests to measure speech, language, and cognition. Final score is derived from principle components analysis. Collected within 1 month of MRI
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