Cognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia
Cognitive Reserve and Linguistic Resilience in Bilingual Hispanics With Primary Progressive Aphasia
1 other identifier
interventional
60
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
June 10, 2026
June 1, 2026
4.6 years
February 3, 2023
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Aphasia Impact Questionnaire (AIQ)
Pre-phase 1, Post-phase 2 (9 weeks from treatment onset)
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
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
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
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
Other Outcomes (1)
Post-treatment Communication Survey
Post-treatment (approximately 6-12 weeks after treatment onset)
Study Arms (2)
Lexical Retrieval Training
EXPERIMENTALNaming intervention for individuals with logopenic or semantic variant PPA.
Video Implemented Script Training for Aphasia
EXPERIMENTALScript training intervention for individuals with nonfluent/agrammatic PPA.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Texas at Austin
Austin, Texas, 78752, United States
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Related Publications (15)
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: 26346123BACKGROUNDSzatloczki 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: 26539107BACKGROUNDMesulam MM. Slowly progressive aphasia without generalized dementia. Ann Neurol. 1982 Jun;11(6):592-8. doi: 10.1002/ana.410110607.
PMID: 7114808BACKGROUNDMontembeault 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: 30186225BACKGROUNDGorno-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: 21325651BACKGROUNDCarthery-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: 29213828BACKGROUNDBialystok 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: 17125807BACKGROUNDAlladi 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: 28322905BACKGROUNDAlladi S, Bak TH, Duggirala V, Surampudi B, Shailaja M, Shukla AK, Chaudhuri JR, Kaul S. Bilingualism delays age at onset of dementia, independent of education and immigration status. Neurology. 2013 Nov 26;81(22):1938-44. doi: 10.1212/01.wnl.0000436620.33155.a4. Epub 2013 Nov 6.
PMID: 24198291BACKGROUNDde Leon J, Grasso SM, Welch A, Miller Z, Shwe W, Rabinovici GD, Miller BL, Henry ML, Gorno-Tempini ML. Effects of bilingualism on age at onset in two clinical Alzheimer's disease variants. Alzheimers Dement. 2020 Dec;16(12):1704-1713. doi: 10.1002/alz.12170. Epub 2020 Sep 3.
PMID: 32881346BACKGROUNDCosta AS, Jokel R, Villarejo A, Llamas-Velasco S, Domoto-Reilley K, Wojtala J, Reetz K, Machado A. Bilingualism in Primary Progressive Aphasia: A Retrospective Study on Clinical and Language Characteristics. Alzheimer Dis Assoc Disord. 2019 Jan-Mar;33(1):47-53. doi: 10.1097/WAD.0000000000000288.
PMID: 30640254BACKGROUNDGrasso SM, Pena ED, Kazemi N, Mirzapour H, Neupane R, Bonakdarpour B, Gorno-Tempini ML, Henry ML. Treatment for Anomia in Bilingual Speakers with Progressive Aphasia. Brain Sci. 2021 Oct 20;11(11):1371. doi: 10.3390/brainsci11111371.
PMID: 34827370BACKGROUNDGrasso SM, Shuster KM, Henry ML. Comparing the effects of clinician and caregiver-administered lexical retrieval training for progressive anomia. Neuropsychol Rehabil. 2019 Jul;29(6):866-895. doi: 10.1080/09602011.2017.1339358. Epub 2017 Jun 30.
PMID: 28662598BACKGROUNDHenry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101.
PMID: 29718131BACKGROUNDHenry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7.
PMID: 31390290BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 23, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- 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.
- 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.
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.