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NCT Number: NCT05741853

Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers 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.

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Key information

Conditions

Primary Progressive Aphasia Alzheimer Disease Aphasia Aphasia, Primary Progressive Apraxia, Motor Apraxias Articulation Disorders Bilingual Aphasia Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Dementia, Frontotemporal Dysarthria Frontotemporal Dementia Frontotemporal Lobar Degeneration Language Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurodevelopmental Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Psychomotor Disorders Signs and Symptoms Speech Disorders TDP-43 Proteinopathies Tauopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-Implemented Script Training for Aphasia (VISTA)

Behavioral

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

Lexical Retrieval Training (LRT)

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Wagner Rodríguez, M.S., CCC-SLP

CONTACT

[email protected]

512-471-4119

Sponsors and collaborators

Lead sponsor

Stephanie Grasso

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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