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

November 10, 2025 updated by: University of Texas at Austin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Miguel A Santos Santos, MD
        • Contact:
  • United States
    • Texas
      • Austin, Texas, United States, 78752
        • Recruiting
        • University of Texas at Austin
        • Contact:
        • Principal Investigator:
          • Stephanie M Grasso, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent correct intelligible words from trained/untrained scripts
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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).
Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)
Connected Speech Features: Type-token ratio
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-treatment Communication Survey
Time Frame: 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.
Post-treatment (approximately 6-12 weeks after treatment onset)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG080470 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data generated from this project will be shared via peer reviewed journal publications as well as through national and international conferences. All peer-reviewed manuscripts will be made available via PubMed Central, in adherence to the NIH Public Access Policy. Intervention protocols, de-identified summary data, and software code/scripts used for data analysis will be made publicly available upon publication of trial results. De-identified data from individual participants may be made available to the scientific community with approved data use and sharing agreements between the University of Texas, Hospital Sant Pau, Hospital Clínic de Barcelona, and requesting institutions or entities, consistent with institution policy.

IPD Sharing Time Frame

Intervention protocols, de-identified summary data, and software code/scripts used for data analysis will be made publicly available upon publication of trial results.

IPD Sharing Access Criteria

De-identified data from individual participants may be made available to the scientific community with approved data use and sharing agreements between the University of Texas, Hospital Sant Pau, Hospital Clínic de Barcelona, and requesting institutions or entities, consistent with institution policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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