BUILD: Brain-based Understanding of Individual Language Differences After Stroke

Sponsor

Georgetown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04991519

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Drexel University (Other), MedStar National Rehabilitation Network (Other)

400

Enrollment

Location

117.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia Stroke Alexia

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Aug 30, 2028

Anticipated Study Completion Date :

Aug 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Stroke Survivors Participants have had a left-hemisphere stroke with or without aphasia, or a stroke elsewhere in the brain causing aphasia. They are given a series of standardized and in-house tests of language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.
Controls Participants are matched to aphasia cohort in age, educational background, race, and gender but have no history of brain injury. They are also given a series of standardized and in-house tests of language and cognition to provide a detailed profile of strengths and weaknesses, plus an MRI.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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