Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary… (NCT05741853) | Clinical Trial Compass
RecruitingNot Applicable
Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
United States, Spain60 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically for bilingual speakers with Primary Progressive Aphasia, could you help me understand whether my particular language background and current communication abilities would make this kind of speech-language intervention worth exploring?
2This study is measuring improvement on trained scripts and spoken word naming — given how my PPA is currently progressing, is there a realistic window where this type of practice-based therapy might still be meaningful for me?
3The trial seems to focus on 'cognitive reserve' as a factor in how people respond to speech therapy — what does that mean in my case, and is it something my current cognitive profile supports?
4Since this is a Phase NA research study rather than a standard treatment trial, how does that affect what's already known about the safety and real-world benefit of this intervention compared to the speech-language therapy I might receive outside of a study?
5Are there standard speech-language therapy options already available to me that I should consider first, or would participating in this trial be a reasonable way to access structured intervention while also contributing to research on bilingual PPA?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent correct intelligible words from trained/untrained scripts
Timeframe: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment
2
Percent correct spoken naming of trained/untrained nouns
Timeframe: Pre-phase 1, post-phase1/pre-phase 2 (4.5 weeks from treatment onset), post-phase 2 (9 weeks from treatment onset), 6 months and 1 year post-treatment