Clinical trial NCT05741853: Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
Official title: Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Progressive Aphasia
Dementia
Dementia, Frontotemporal
Alzheimer Disease
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
Apraxia, Motor
Dysarthria
Communication Disorders
Language Disorders
Speech Disorders
Neurocognitive Disorders
Aphasia
Bilingual Aphasia
Keywords: Dementia, ADRD
Bilingualism
Multilingualism
Primary Progressive Aphasia
Bilingual Primary Progressive Aphasia
Cognitive Reserve
Language Decline
Bilingual Language Decline
Speech-Language Therapy
Bilingual Speech-Language Therapy
Spanish speakers
Spanish-Catalan Bilinguals
Spanish-English Bilinguals
Hispanic
Catalán
Catalan
Spanish
Castellano
Speech Therapy
Latino
Cognition
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Clinic of Barcelona
First posted: 2023-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Aphasia Impact Questionnaire (AIQ)
timeFrame: Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)
measure: Connected Speech Features: Type-token ratio
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
measure: Connected Speech Features: Mean length of utterance
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
measure: Acoustic Features: Articulation Rate
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
measure: Acoustic Features: Speech-to-pause time
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
Other outcomes:
measure: Post-treatment Communication Survey
timeFrame: Post-treatment (approximately 6-12 weeks after treatment onset)
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: University of Texas at Austin
name: Stephanie M Grasso, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Miguel Ángel Santos Santos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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