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NCT Number: NCT06739967

Speech and Language Interventions for Italian People With PPA

Primary progressive aphasia (PPA) is an umbrella term used to refer to several clinical variants that manifest as an insidious deterioration of speech/language skills, usually due to frontotemporal lobar degeneration and/or Alzheimer's disease. Consensus criteria have been proposed by an international community regarding the sub-classification of PPA into three variants: (1) semantic variant PPA, characterized by impaired confrontation naming and single-word comprehension; (2) logopenic variant PPA), characterised by word-finding difficulties and sentence repetition deficits; and (3) non-fluent variant, characterised by agrammatism with or without apraxia of speech.

Speech and language therapists (SLTs) play a crucial role in the diagnostic process and in setting a therapeutic path along with monitoring the evolution of the clinical picture. Despite growing evidence supporting the benefits of speech-language intervention, the frequency with which individuals with PPA are referred for speech and language services, is suboptimal likely due to skepticism regarding the value of speech and language therapy in the context of neurodegeneration, the scarcity of SLTs with expertise in the treatment of PPA, the lack of awareness regarding the role of the SLT amongst referrers, and the geographical barriers that impede access to in-person speech and language services. In Italy, patients with PPA are rarely offered treatment options due to a lack of understanding of the disorder on the part of health professionals and erroneous assumptions regarding the utility of treatment in patients facing a worsening prognosis.

The primary aim of this pilot study is to develop tailored speech and language interventions for patients with different variants of PPA by addressing their linguistic and cognitive difficulties. Secondly, to explore the intervention's effect also on untreated tasks and assess the long-term maintenance of the proposed interventions by monitoring patients for up to six months. Finally, in each PPA variant, the investigators aim to investigate which variables among the sociodemographic, clinical, linguistic/cognitive, and brain MRI features at baseline predict successful clinical results, as well as which structural and functional brain changes are associated with speech and language improvements.

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Key information

Conditions

Primary Progressive Aphasia(PPA) Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia 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 Signs and Symptoms Speech Disorders TDP-43 Proteinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy

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About this study

A total of 30 PPA patients will be recruited, with a clinical and imaging-supported diagnosis of PPA according to the current diagnostic criteria, and MMSE>15. At the study entry (T0), all patients will undergo a clinical interview, a neurological and neuropsychological evaluation, and a speech and language assessment. All these visits will be repeated soon after the intervention (at week 5, W5), at 3 months (M3), and at 6 months (M6) post-intervention. Specifically, measures of patient's and caregivers' satisfaction and patients' functional communication abilities will be collected as primary outcomes. At baseline (T0) and after intervention (W5), all patients recruited at IRCCS San Raffaele and 40% of patients recruited at IRCCS Maugeri Clinical and Scientific Institute will also perform a brain structural and functional MRI. Thirty healthy controls, matched with PPA cases for age and sex, will be also recruited. Only at baseline (T0), all controls will undergo the same visits as the PPA patients, as well as the brain MRI scan. IRCCS Maugeri Clinical and Scientific Institute will be specifically in charge of the development of the SLT protocols, for the online administration of tailored speech and language interventions and for data analysis. IRCCS Ospedale San Raffaele Milano will be specifically in charge of brain structural and functional MRI acquisition, the definition of task-based functional MRI paradigms, and MRI analysis. This unit will also recruit and collect data on the entire sample of healthy controls. Brain structural and functional changes associated with SLT interventions using the most advanced MRI techniques will be investigated. The sociodemographic, clinical, language, speech, and MRI features obtained in patients will be processed through machine learning to develop a computation paradigm that better defines their prediction value for the intervention's efficacy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of PPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
  • Mild PPA defined using the Progressive Aphasia Severity Scale (PASS)
  • Age between 40 and 85 years
  • Patients with Italian mother tongue
  • Patients with the ability to sign the informed consent
  • Patients with the ability to comply with the study procedures
  • Patients with stable pharmacological treatment for at least 4 weeks.

Exclusion criteria

  • Mini-Mental State Exam (MMSE) Score <15
  • Presence of other neurological or psychiatric diseases, including cerebrovascular disease
  • Severe and uncorrected hearing loss or visual disturbances
  • Inability to repeat multi-syllable words (4 syllables)
  • Concurrent participation in other pharmacological and non-pharmacological experimental studies

Treatment and study plan

Behavioral Treatment

Behavioral

The SLT intervention will be entirely administered online through a web-based platform. While each of the treatments will engage semantics, phonology, and orthography, the protocols will be tailored relative to the characteristics of each PPA variant. Patients with svPPA and lvPPA will undergo a lexical retrieval training (LRT) intervention implemented using a training cascade.

Patients with nfvPPA will undergo Video-implemented Script Training (VISTA), a choral reading approach training accurate production of functional scripts. The method is based on that implemented in American-English individuals with PPA and aims at improving grammar and motor aspects of speech production by taking advantage of repetitive practice and automaticity.

Other names: Speech and Language Therapy, SLT

Primary outcomes

  1. Change in measure of naming after Lexical Retrieval Training (LRT)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Number of correct spoken and written naming of trained and untrained items for patients undergoing the LRT treatment (lvPPA/svPPA)

  2. Change in number of articulatory and grammatical errors

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    The percentage of script words produced correctly for VISTA for trained and untrained scripts.

  3. Change in measures of patients and caregivers satisfaction and patients functional communication abilities

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    A Likert scale evaluating relevant categories of functional verbal communication skills in daily situations will be used. The score ranges from 0 - 30. High scores are more favorable, meaning that high scores indicate less interference in participation. The summary scores will be converted to IRT theta values (logit scale). On the logit scale, scores range from -3.0 to +3.0 with 0 logits representing the mean for the calibration sample. High scores are preferable.

  4. Change on untrained probes within each clinical variant

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Number of untrained items correctly identified

Secondary outcomes

  1. Change in measure of oral production as assessed by Picture description subtests

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    To examine the informativeness and efficiency of communication from the connected speech sampled with the Nicholas and Brookshire (1993) picture description task and the Screening for Aphasia in Neurodegeneration (SAND) picture task.

  2. Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Communication Outcome After Stroke (COAST) is a measure of the functional communication in daily activities and of the impact of the quality of life point of view of aphasia patient (COAST total score range: min= 0, max= 80, higher score=better outcome) and their carer (Carer COAST total score range: min= 0, max= 80, higher score=better outcome)

  3. Change in measure of naming as assessed by Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 14, higher score=better outcome), living score (score range: min= 0, max= 7, higher score=better outcome) and non-living score (score range: min= 0, max= 7, higher score=better outcome).

  4. Change in measure of comprehension as assessed by Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 8, higher score=better outcome.

  5. Change in measure of comprehension as assessed by Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 12, higher score=better outcome), living score (score range: min= 0, max= 6, higher score=better outcome) and non-living score (score range: min= 0, max= 6, higher score=better outcome).

  6. Change in measure of repetition as assessed by Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 10, higher score=better outcome), words score (score range: min= 0, max= 6, higher score=better outcome) and non-words score (score range: min= 0, max= 4, higher score=better outcome).

  7. Change in measure of repetition as assessed by Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 6, higher score=better outcome), predictable sentences score (score range: min= 0, max= 3, higher score=better outcome) and unpredictable sentences score (score range: min= 0, max= 3, higher score=better outcome).

  8. Change in measure of reading as assessed by Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 16, higher score=better outcome), words score (score range: min= 0, max= 12, higher score=better outcome) and non-words score (score range: min= 0, max= 4, higher score=better outcome).

  9. Change in measure of writing as assessed by Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides Information Units score (score range: min= 0, max= 6, higher score=better outcome), total number of words score (score range: min= 0, max= no limits, higher score=better outcome), number of nouns/total number of words score (score range: min= 0, max= 1, higher score=better outcome), number of verbs/total number of words (score range: min= 0, max= 1, higher score=better outcome), number of correct syntactic structures/total number of syntactic structures score (score range: min= 0, max= 1, higher score=better outcome), number of orthographic errors score (score range: min= 0, max= no limits, higher score=worse outcome), number of lexico-semantic errors/number of words score (score range: min= 0, max= 1, higher score=worse outcome).

  10. Change in measure of semantics as assessed by Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 4, higher score=better outcome.

  11. Change in measure of naming as assessed by Subtest from CAGI battery

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Naming subtest from CAGI: score range: min= 0, max= 48, higher score=better outcome.

  12. Change in measure of comprehension as assessed by Single-word comprehension subtest from CAGI

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Single-word comprehension subtest from CAGI: score range: min= 0, max= 48, higher score=better outcome.

  13. Change in measure of Sentence Production as measured by Northwestern Anagram Test-Italian (Nat-I)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    The NAT-I is a 22-item test: score range: min= 0, max= 22, higher score=better outcome.

  14. Change in measure of comprehension as assessed by Sentence Comprehension Task

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Sentence Comprehension Task: total score range: min= 0, max= 48, higher score=better outcome.

  15. Change in in measure of verb and sentence processing as measured by the Italian version of the Northwestern Assessment of Verbs and Sentences (NAVS-I)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    NAVS-I encompasses three subtests: Verb Naming Task (VNT), Verb Comprehension Task (VCT), and Argument Structure Production Task (ASPT).

  16. Change in measure of semantics as assessed by Semantic association Test (SAT)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    SAT: total score range: min= 0, max= 76, higher score=better outcome.

  17. Change in measure of repetition as assessed by Repetition subtest from Esame Neuropsicologico per l'Afasia (ENPA)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Repetition subtest from ENPA: score range: min= 0, max= 15, higher score=better outcome.

  18. Change in measure of repetition as assessed by Repetition subtest from Aachener Aphasie Test (AAT)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Repetition subtest from AAT: score range: min= 0, max= 150, higher score=better outcome.

  19. Changes in measures of motor speech as assessed by the Motor Speech Evaluation (MSE)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Motor Speech Evaluation (MSE) score range: min= 0, max= 30, higher score=better outcome.

  20. Change in measures of Verbal fluency as measured by Phonemic Fluency Test and Semantic Fluency Test

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Phonemic Fluency Test: higher score= better outcome. Semantic Fluency Test: higher score= better outcome.

  21. Change in measure of global cognitive impairment as assessed by Mini Mental State Examination (MMSE)

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Mini Mental State Examination (MMSE): score range: min= 0, max= 30, higher score=better outcome.

  22. Change in dementia severity as assessed by Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes

    Time frame: From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months

    Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes (score range: min= 0, max= 24, higher score=worse outcome).

  23. Structural MRI scan

    Time frame: At baseline, from enrollment to the end of treatment at 5 weeks

    Measure of global and regional volumes of interest (such as whole brain and temporal lobes). Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.

  24. Functional MRI scan

    Time frame: At baseline, from enrollment to the end of treatment at 5 weeks

    Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome. Connectivity between brain regions measured using diffusion tensor MRI and resting state functional MRI.

Study contacts

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

Christian Lunetta, MD

CONTACT

[email protected]

+39 02 5072 5266

Petronilla Battista, PhD

CONTACT

[email protected]

+390807814331

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

Speech and Language-Tailored Interventions for People With Primary Progressive Aphasia

Acronym: PPA-rehab

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Feb 20, 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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