Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia

Not Applicable

Recruiting

• Conditions: Primary Progressive Aphasia; Frontotemporal Lobar Degeneration; Speech Disorders; Aphasia; Neurodegenerative Diseases; Communication Disorders; Bilingual Aphasia; Dementia; Apraxia, Motor; Dysarthria
• Interventions: Behavioral: Video-Implemented Script Training for Aphasia (VISTA); Behavioral: Lexical Retrieval Training (LRT)

• Registration Number: NCT05741853
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lexical Retrieval Training	Video-Implemented Script Training for Aphasia (VISTA)	Naming intervention for individuals with logopenic or semantic variant PPA.
Video Implemented Script Training for Aphasia	Video-Implemented Script Training for Aphasia (VISTA)	Script training intervention for individuals with nonfluent/agrammatic PPA.
Video Implemented Script Training for Aphasia	Lexical Retrieval Training (LRT)	Script training intervention for individuals with nonfluent/agrammatic PPA.
Lexical Retrieval Training	Lexical Retrieval Training (LRT)	Naming intervention for individuals with logopenic or semantic variant PPA.

Primary Outcome Measures

Name	Time	Method
Percent correct intelligible words from trained/untrained scripts	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	Percent of intelligible, scripted words for trained scripts and untrained scripts
Percent correct spoken naming of trained/untrained nouns	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	Percent of correctly named trained pictured items and untrained pictured items

Secondary Outcome Measures

Name	Time	Method
Connected Speech Features: Type-token ratio	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	Total number of unique words (types) divided by the total number of words (tokens) derived from connected speech samples (script topic probes, picture description, and personal narrative).
Connected Speech Features: Mean length of utterance	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	Average number of words produced per utterance derived from connected speech samples (script topic probes, picture description, and personal narrative).
Acoustic Features: Articulation Rate	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	Syllables per second of phonated time derived from connected speech samples (script topic probes, picture description, and personal narrative).
Aphasia Impact Questionnaire (AIQ)	Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)	Patient reported outcome measure for use with people with aphasia comprising three sections: activities, participation and emotional state/wellbeing. Uses a 5 point pictorial rating scale. The minimum score is 0 (best) and the maximum is 4 (worst).
Acoustic Features: Speech-to-pause time	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	Phonated time divided by pause time in the sample derived from connected speech samples (script topic probes, picture description, and personal narrative).

Trial Locations

Locations (3)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain