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

Study Overview
=================
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.

Official Title
-----------------
Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia

Conditions
-----------------
Dementia, Primary Progressive Aphasia, Dementia, Frontotemporal, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Lobar Degeneration, Apraxia, Motor, Dysarthria, Communication Disorders, Language Disorders, Speech Disorders, Neurocognitive Disorders, Aphasia, Bilingual Aphasia

Intervention / Treatment
-----------------
* Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
* Behavioral: Lexical Retrieval Training (LRT)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lexical Retrieval Training<br>Naming intervention for individuals with logopenic or semantic variant PPA. | Behavioral: Video-Implemented Script Training for Aphasia (VISTA)<br>* Participants with nonfluent/agrammatic variant primary progressive aphasia (PPA) or a predominantly nonfluent profile work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 5-7 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.<br>* Other names: Script training;Behavioral: Lexical Retrieval Training (LRT)<br>* Participants with logopenic variant PPA, participants with semantic variant PPA, and participants with a predominantly anomic profile will work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 5-7 times per week.<br>* Other names: Naming intervention;|
| Experimental: Video Implemented Script Training for Aphasia<br>Script training intervention for individuals with nonfluent/agrammatic PPA. | Behavioral: Video-Implemented Script Training for Aphasia (VISTA)<br>* Participants with nonfluent/agrammatic variant primary progressive aphasia (PPA) or a predominantly nonfluent profile work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 5-7 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.<br>* Other names: Script training;Behavioral: Lexical Retrieval Training (LRT)<br>* Participants with logopenic variant PPA, participants with semantic variant PPA, and participants with a predominantly anomic profile will work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 5-7 times per week.<br>* Other names: Naming intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent correct intelligible words from trained/untrained scripts | Percent of intelligible, scripted words for trained scripts and 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 correct spoken naming of trained/untrained nouns | Percent of correctly named trained pictured items and untrained pictured items | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aphasia Impact Questionnaire (AIQ) | 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). | Pre-phase 1, Post-phase 2 (9 weeks from treatment onset) | 
| Connected Speech Features: Type-token ratio | 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). | 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 | 
| Connected Speech Features: Mean length of utterance | Average number of words produced per utterance derived from connected speech samples (script topic probes, picture description, and personal narrative). | 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 | 
| Acoustic Features: Articulation Rate | Syllables per second of phonated time derived from connected speech samples (script topic probes, picture description, and personal narrative). | 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 | 
| Acoustic Features: Speech-to-pause time | Phonated time divided by pause time in the sample derived from connected speech samples (script topic probes, picture description, and personal narrative). | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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