- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02916524
Przewidywanie wyników rehabilitacji w afazji dwujęzycznej za pomocą modelowania komputerowego (PROCoM)
Randomizowane badanie z podwójnie ślepą próbą badające wykorzystanie modelowania komputerowego do przewidywania wyników rehabilitacji w afazji dwujęzycznej
The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
San Francisco, California, Stany Zjednoczone, 94132
- San Francisco State University
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Boston University Sargent College
-
-
Texas
-
Austin, Texas, Stany Zjednoczone, 78757
- Austin Speech Labs
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Any number of years of education
- Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
- Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
- Aphasia resulting from stroke or dementia
- Naming deficits must be present with concurrent lexical/semantic impairment
- Visual and auditory acuity sufficient for all assessment and treatment procedures
- Ability to understand study and follow study procedures for the entire length of the study
Exclusion Criteria:
- Premorbid history of speech/language disorder
- Proficient in more than just Spanish and English (or Chinese and English)
- Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
- Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
- Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
- Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
- Inability or unwillingness of individual to give written informed consent
- Diagnosed with mental illness other than active depression
- Neurological condition other than that which resulted in aphasia
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Model-based
Semantic Feature Analysis training will be provided in the language that was selected by the computational model. |
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed. |
|
Aktywny komparator: Model-opposite
Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model. |
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Word Retrieval Accuracy in English and Spanish
Ramy czasowe: Through study completion, an average of 10 weeks
|
Accuracy of naming black and white pictures that are both trained and untrained in English and Spanish will be assessed in naming tests. These tests were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. Proportion accuracy was calculated for each set of items for every testing session. Baseline scores were compared to end of treatment scores to obtain individual effect sizes for each sets of items for each participant. |
Through study completion, an average of 10 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) in Both Languages
Ramy czasowe: Baseline, post-treatment (on average 10 weeks)
|
The PALPA/Evaluación del Procesamiento Lingüístico en la Afasia (EPLA) is a standardized assessment for reading simple words and spoken words in both English and Spanish out of 30 words. |
Baseline, post-treatment (on average 10 weeks)
|
|
Boston Naming Test (BNT) in Both Languages
Ramy czasowe: Baseline, post-treatment (on average 10 weeks)
|
The BNT is a standardized naming assessment that includes 60 pictures that can be named in either English or Spanish. |
Baseline, post-treatment (on average 10 weeks)
|
|
Western Aphasia Battery (WAB-R) in Both Languages
Ramy czasowe: Baseline, post-treatment (on average 10 weeks)
|
Western Aphasia Battery:The WAB-R is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia, with excellent reliability and validity. The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes. Range is 0 t0 100. |
Baseline, post-treatment (on average 10 weeks)
|
|
Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
Ramy czasowe: Baseline, post-treatment (on average 10 weeks)
|
The Pyramids and Palm Trees is a non-verbal (language-independent) semantic processing assessment that includes 3 pictures of which the person has to decide which two go together. There are 52 items in this test with a range of 1-52. |
Baseline, post-treatment (on average 10 weeks)
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Swathi Kiran, PhD, Boston University
Publikacje i pomocne linki
Publikacje ogólne
- Penaloza C, Dekhtyar M, Scimeca M, Carpenter E, Mukadam N, Kiran S. Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. BMJ Open. 2020 Nov 18;10(11):e040495. doi: 10.1136/bmjopen-2020-040495.
- Russell-Meill M, Carpenter E, Marte MJ, Scimeca M, Penaloza C, Kiran S. Measurement of cross-language and cross-domain generalization following semantic feature-based anomia treatment in bilingual aphasia. Neuropsychol Rehabil. 2026 Apr;36(3):544-570. doi: 10.1080/09602011.2025.2522196. Epub 2025 Jun 26.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4492E
- U01DC014922-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .