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

27. juli 2021 opdateret af: Georgetown University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Alycia Laks, MS, CCC-SLP
Telefonnummer: 202-687-5205
E-mail: al1579@georgetown.edu

Undersøgelse Kontakt Backup

Navn: Elizabeth Lacey, PhD
Telefonnummer: 202-270-6497
E-mail: ehl4@georgetown.edu

Studiesteder

Forenede Stater
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20057
    - Rekruttering
    - Georgetown University Medical Center
    - Kontakt:
      
      Sachi Paul, BA
      
      Telefonnummer: 202-687-5205
      
      E-mail: sp1446@georgetown.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
MP-RAGE (Magnetization Prepared Rapid Acquisition Gradient Echo) Tidsramme: Samlet inden for 1 måned efter adfærdstestning	En del af MR-sekvens, der måler dyb grå substans struktur.	Samlet inden for 1 måned efter adfærdstestning
DTI (Diffusion Tensor Imaging) Tidsramme: Samlet inden for 1 måned efter adfærdstestning	En del af MR-sekvens, der måler hastigheden af vanddiffusion mellem celler for at forstå og skabe et kort over interne strukturer.	Samlet inden for 1 måned efter adfærdstestning
Adfærdstest Tidsramme: Samlet inden for 1 måned efter MR	Batteri af standard kliniske og interne adfærdstests til måling af tale, sprog og kognition. Den endelige score er afledt af principkomponentanalyse.	Samlet inden for 1 måned efter MR

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Georgetown University

Samarbejdspartnere

National Institute on Deafness and Other Communication Disorders (NIDCD)

Drexel University

MedStar National Rehabilitation Network

Efterforskere

Ledende efterforsker: Peter Turkeltaub, MD,PhD, Georgetown University; MedStar National Rehabilitation Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2018

Primær færdiggørelse (Forventet)

30. august 2028

Studieafslutning (Forventet)

30. august 2028

Datoer for studieregistrering

Først indsendt

1. juli 2021

Først indsendt, der opfyldte QC-kriterier

27. juli 2021

Først opslået (Faktiske)

5. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)