Brain-based Understanding of Individual Language Differences After Stroke

Stroke Clinical Trial

— BUILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991519
• Other study ID #: BUILD
• Secondary ID: R01DC014960
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Alexia
• Aphasia
• Stroke

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