Brain-based Understanding of Individual Language Differences After Stroke (BUILD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia; Alexia

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Alycia Laks, MS, CCC-SLP; Phone Number: 202-687-5205; Email: al1579@georgetown.edu
• Study Contact Backup: Name: Elizabeth Lacey, PhD; Phone Number: 202-270-6497; Email: ehl4@georgetown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Recruiting
      • Georgetown University Medical Center
      • Contact: Sachi Paul, BA; Phone Number: 202-687-5205; Email: sp1446@georgetown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants are survivors of left hemisphere stroke with or without aphasia, or people with aphasia due to strokes in other parts of the brain. We recruit participants primarily from the Washington, DC region, but some participants may travel from farther away to participate in the study. We aim for our participants to be fully representative of the diversity of individuals with stroke in the general population. Control participants are matched to stroke survivors on age, gender, race, educational background, and stroke risk factors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); Drexel University; MedStar National Rehabilitation Network
• Investigators: Principal Investigator: Peter Turkeltaub, MD,PhD, Georgetown University; MedStar National Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): August 30, 2028
• Study Completion (Anticipated): August 30, 2028

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: stroke; language; brain injury; apraxia; speech; aphasia; reading; alexia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: BUILD; R01DC014960 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No