Clinical trial NCT04991519: Brain-based Understanding of Individual Language Differences After Stroke
Official title: Understanding the Brain Basis of Language and Cognitive Functions Through the Study of Individuals With Brain Injury and Healthy Controls
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aphasia
Stroke
Alexia
Keywords: aphasia
stroke
brain injury
speech
language
reading
alexia
apraxia
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Drexel University
name: MedStar National Rehabilitation Network
First posted: 2021-08-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)
timeFrame: Collected within 1 month of behavioral testing
measure: DTI (Diffusion Tensor Imaging)
timeFrame: Collected within 1 month of behavioral testing
measure: Behavioral testing
timeFrame: Collected within 1 month of MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University; MedStar National Rehabilitation Hospital
name: Peter Turkeltaub, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: