Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04991519

Brain-based Understanding of Individual Language Differences After Stroke

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)

    Time frame: Collected within 1 month of behavioral testing

    Part of MRI sequence that measures deep grey matter structure.

  2. DTI (Diffusion Tensor Imaging)

    Time frame: 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.

  3. Behavioral testing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BUILD

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.