AphasiaBUILDNCT04991519
Brain-based Understanding of Individual Language Differences After Stroke
An observational study of Aphasia and Stroke, run by Georgetown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
About this study
Official title: 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.
- Keywords
- aphasia, stroke, brain injury, speech, language, reading, alexia, apraxia
- Medical subject headings
- Aphasia, Stroke, Dyslexia, Brain Injuries, Speech, Language, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo)
Part of MRI sequence that measures deep grey matter structure.
Measured: 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.
Measured: 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.
Measured: Collected within 1 month of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Nov 2018
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Drexel University, MedStar National Rehabilitation Network
- Responsible party
- Sponsor
- Investigators
- Peter Turkeltaub, MD,PhD, Principal investigator, Georgetown University; MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991519
- Sponsor's protocol ID
- BUILD
- Other IDs
- R01DC014960
- Acronym
- BUILD
- Status last verified
- Apr 2024
- First submitted
- 1 Jul 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vladyko N, DeMarco AT, Turkeltaub PE. Right Hemisphere Functional Connectivity Increases in Proportion to Left Hemisphere Lesion Size, but Not Within the Language Network. Hum Brain Mapp. 2026 Sep;47(13):e70631. doi: 10.1002/hbm.70631.
PubMed 42698375
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Brain Basis of Language and Cognitive Functions Through the Study of Individuals With Brain Injury and Healthy Controls
- ClinicalTrials.gov ID
- NCT04991519
- Acronym / sponsor ID
- BUILD / BUILD
- Keywords
- aphasia, stroke, brain injury, speech, language, reading, alexia, apraxia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Drexel University, MedStar National Rehabilitation Network
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age >=18
- Stroke in left hemisphere of brain with or without aphasia, or stroke elsewhere causing aphasia
- Learned English at 8 years or younger
- Age >=18
- No history of brain injury resulting from stroke, trauma, infection (i.e. encephalitis), or tumor
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 42698375Vladyko N, DeMarco AT, Turkeltaub PE. Right Hemisphere Functional Connectivity Increases in Proportion to Left Hemisphere Lesion Size, but Not Within the Language Network. Hum Brain Mapp. 2026 Sep;47(13):e70631. doi: 10.1002/hbm.70631.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Turkeltaub, MD,PhD principal investigator
Georgetown University; MedStar National Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia and Stroke, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo) (time frame: Collected within 1 month of behavioral testing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.