Brain-based Understanding of Individual Language Differences After Stroke

NCT04991519 | Active Not Recruiting

• 2 other identifiers: BUILDR01DC014960
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke; Alexia

Keywords

aphasia; stroke; brain injury; speech; language; reading; alexia; apraxia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Pacemaker or magnetic metal in the body that is not MRI compatible
• Pregnancy
• Claustrophobia

Sponsors & Collaborators

• Georgetown University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Drexel University: collaborator
• MedStar National Rehabilitation Network: collaborator

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke; Dyslexia; Brain Injuries; Speech; Language; Apraxias

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Specific Learning Disorder; Learning Disabilities; Neurodevelopmental Disorders; Mental Disorders; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Verbal Behavior; Communication; Behavior; Psychomotor Disorders

Study Officials

• Peter Turkeltaub, MD,PhD

  Georgetown University; MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 5, 2021
• Study Start: November 1, 2018
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: November 12, 2024

Record last verified: 2024-04

Locations

US (1)