Ireland
--:--IST
Recruiting Observational

Speech and Language Interventions for Italian People With PPA

NCT06739967 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-09-01
Last updated
2026-02-20

Condition(s) studied

Primary Progressive Aphasia(PPA)

Investigational drug(s) / intervention(s)

Behavioral Treatment

Behavioral Treatment: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in measure of naming after Lexical Retrieval Training (LRT) — 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)
  • Change in number of articulatory and grammatical errors — 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.
  • Change in measures of patients and caregivers satisfaction and patients functional communication abilities — 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.
  • Change on untrained probes within each clinical variant — From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months
    Number of untrained items correctly identified

Trial sites (2)

FacilityCityRegionStatus
Istituti Clinici Scientifici Maugeri IRCCS Bari Italy Recruiting
IRCCS Ospedale San Raffaele Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06739967 on ClinicalTrials.gov ↗ ← All trials in Italy