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

Sponsor
University of Texas at Austin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05741853
Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other), Hospital Clinic of Barcelona (Other)
60
2
2
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30
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
  • Behavioral: Lexical Retrieval Training (LRT)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
Anticipated Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Nov 30, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lexical Retrieval Training

Naming intervention for individuals with logopenic or semantic variant PPA.

Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
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.
Other Names:
  • Script training
  • Behavioral: Lexical Retrieval Training (LRT)
    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.
    Other Names:
  • Naming intervention
  • Experimental: Video Implemented Script Training for Aphasia

    Script training intervention for individuals with nonfluent/agrammatic PPA.

    Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
    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.
    Other Names:
  • Script training
  • Behavioral: Lexical Retrieval Training (LRT)
    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.
    Other Names:
  • Naming intervention
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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).

    2. 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).

    3. 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).

    4. 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).

    5. 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).

    Other Outcome Measures

    1. Post-treatment Communication Survey [Post-treatment (approximately 6-12 weeks after treatment onset)]

      Survey characterizing perceived response to treatment. Scale scale options are as follows: "a lot worse", "worse", "somewhat worse", "unchanged", "somewhat better", "better", and "a lot better." There are seven levels with "a lot worse" being the lowest rating and "a lot better" being the best rating.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al.,
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas at Austin Austin Texas United States 78752
    2 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

    • University of Texas at Austin
    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Hospital Clinic of Barcelona

    Investigators

    • Principal Investigator: Stephanie M Grasso, Ph.D, University of Texas at Austin
    • Principal Investigator: Miguel Ángel Santos Santos, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Texas at Austin
    ClinicalTrials.gov Identifier:
    NCT05741853
    Other Study ID Numbers:
    • R01AG080470
    First Posted:
    Feb 23, 2023
    Last Update Posted:
    Feb 23, 2023
    Last Verified:
    Feb 1, 2023

    Study Results

    No Results Posted as of Feb 23, 2023