NCT05741853 Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
| NCT ID | NCT05741853 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stephanie Grasso |
| Condition | Primary Progressive Aphasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-05-01 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Difficulties with speech and language are the first and most notable symptoms of primary progressive aphasia (PPA). While there is evidence that demonstrates positive effects of speech-language treatment for individuals with PPA who only speak one language (monolinguals), there is a significant need for investigating the effects of treatment that is optimized for bilingual speakers with PPA. This stage 2 efficacy clinical trial seeks to establish the effects of culturally and linguistically tailored speech-language interventions administered to bilingual individuals with PPA. The overall aim of the intervention component of this study is to establish the relationships between the bilingual experience (e.g., how often each language is used, how "strong" each language is) and treatment response of bilinguals with PPA. Specifically, the investigators will evaluate the benefits of tailored speech-language intervention administered in both languages to bilingual individuals with PPA (60 individuals will be recruited). The investigators will conduct an assessment before treatment, after treatment and at two follow-ups (6 and 12-months post-treatment) in both languages. When possible, a structural scan of the brain (magnetic resonance image) will be collected before treatment in order to identify if brain regions implicated in bilingualism are associated with response to treatment. In addition to the intervention described herein, 30 bilingual individuals with PPA will be recruited to complete behavioral cognitive-linguistic testing and will not receive intervention. Results will provide important knowledge about the neural mechanisms of language re-learning and will address how specific characteristics of bilingualism influence cognitive reserve and linguistic resilience in PPA.
Eligibility Criteria
Inclusion Criteria: * Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011) * Bilingual in Spanish and Catalan or bilingual in Spanish and English * Different proficiency levels across languages are expected, any prior experience in both languages is acceptable * Intervention study: Score of 15 or higher on the Mini-Mental State Examination * Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of 10 or higher on the Mini-Mental State Examination Exclusion Criteria: * Other central nervous system or medical diagnosis that can cause symptoms * Other psychiatric diagnosis that can cause symptoms * Significant, uncorrected visual or hearing impairment that would interfere with participation * Prominent initial non-speech-language impairments (cognitive, behavioral, motoric) * Intervention Study: Score of less than 15 on the Mini-Mental State Examination * Note that this project will also recruit individuals to participate in assessment only, for these individuals the following inclusion criteria applies: Score of less than 10 on the Mini-Mental State Examination
Contact & Investigator
Stephanie M Grasso, Ph.D
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05741853 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Primary Progressive Aphasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05741853 currently recruiting?
Yes, NCT05741853 is actively recruiting participants. Contact the research team at wagner.camille@austin.utexas.edu for enrollment information.
Where is the NCT05741853 trial being conducted?
This trial is being conducted at Austin, United States, Barcelona, Spain, Barcelona, Spain.
Who is sponsoring the NCT05741853 clinical trial?
NCT05741853 is sponsored by Stephanie Grasso. The principal investigator is Stephanie M Grasso, Ph.D at University of Texas at Austin. The trial plans to enroll 60 participants.