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Recruiting NCT05741853

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

No phase Interventional Primary Progressive Aphasia Dementia Dementia, Frontotemporal Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-Implemented Script Training for Aphasia (VISTA), Lexical Retrieval Training (LRT).
Who it may be relevant to
Registry conditions: Primary Progressive Aphasia, Dementia, Dementia, Frontotemporal, Alzheimer Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 independe
  • 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 i

Primary outcome measures

  • 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 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]
Secondary outcome measures (5)
  • Aphasia Impact Questionnaire (AIQ) [Time frame: 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]
  • 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]
  • 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Clínic de Barcelona — Barcelona
United States · 1 center
  • University of Texas at Austin — Austin

Publications

  • Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015. PMID 26346123
  • Szatloczki G, Hoffmann I, Vincze V, Kalman J, Pakaski M. Speaking in Alzheimer's Disease, is That an Early Sign? Importance of Changes in Language Abilities in Alzheimer's Disease. Front Aging Neurosci. 2015 Oct 20;7:195. doi: 10.3389/fnagi.2015.00195. eCollection 2015. PMID 26539107
  • Mesulam MM. Slowly progressive aphasia without generalized dementia. Ann Neurol. 1982 Jun;11(6):592-8. doi: 10.1002/ana.410110607. PMID 7114808
  • Montembeault M, Brambati SM, Gorno-Tempini ML, Migliaccio R. Clinical, Anatomical, and Pathological Features in the Three Variants of Primary Progressive Aphasia: A Review. Front Neurol. 2018 Aug 21;9:692. doi: 10.3389/fneur.2018.00692. eCollection 2018. PMID 30186225
  • Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16. PMID 21325651
  • Carthery-Goulart MT, da Silveira ADC, Machado TH, Mansur LL, Parente MAMP, Senaha MLH, Brucki SMD, Nitrini R. Nonpharmacological interventions for cognitive impairments following primary progressive aphasia: a systematic review of the literature. Dement Neuropsychol. 2013 Jan-Mar;7(1):122-131. doi: 10.1590/S1980-57642013DN70100018. PMID 29213828
  • Bialystok E, Craik FI, Freedman M. Bilingualism as a protection against the onset of symptoms of dementia. Neuropsychologia. 2007 Jan 28;45(2):459-64. doi: 10.1016/j.neuropsychologia.2006.10.009. Epub 2006 Nov 27. PMID 17125807
  • Alladi S, Bak TH, Shailaja M, Gollahalli D, Rajan A, Surampudi B, Hornberger M, Duggirala V, Chaudhuri JR, Kaul S. Bilingualism delays the onset of behavioral but not aphasic forms of frontotemporal dementia. Neuropsychologia. 2017 May;99:207-212. doi: 10.1016/j.neuropsychologia.2017.03.021. Epub 2017 Mar 18. PMID 28322905

Identifiers

NCT: NCT05741853 · R01AG080470

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗