- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02916524
Predikce výsledků rehabilitace u bilingvní afázie pomocí počítačového modelování (PROCoM)
Dvojitě zaslepená randomizovaná studie zkoumající použití počítačového modelování k predikci výsledků rehabilitace u bilingvní afázie
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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California
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San Francisco, California, Spojené státy, 94132
- San Francisco State University
-
-
Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Boston University Sargent College
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Texas
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Austin, Texas, Spojené státy, 78757
- Austin Speech Labs
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Word Retrieval Accuracy in English and Spanish
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) in Both Languages
Časové okno: 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)
|
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Boston Naming Test (BNT) in Both Languages
Časové okno: 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
Časové okno: 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)
|
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Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Swathi Kiran, PhD, Boston University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 4492E
- U01DC014922-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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