Speech and Language Interventions for Italian People With PPA
ConditionPrimary Progressive Aphasia(PPA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients with primary progressive aphasia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Behavioral Treatment
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Speech and Language Tailored Interventions1 intervention
Trial outcomes
Primary outcomes
1
Change in measure of naming after Lexical Retrieval Training (LRT)
Number of correct spoken and written naming of trained and untrained items for patients undergoing the LRT treatment (lvPPA/svPPA)
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months2
Change in number of articulatory and grammatical errors
The percentage of script words produced correctly for VISTA for trained and untrained scripts.
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months3
Change in measures of patients and caregivers satisfaction and patients functional communication abilities
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.
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months4
Change on untrained probes within each clinical variant
Number of untrained items correctly identified
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 MonthsSecondary outcomes
1
Change in measure of oral production as assessed by Picture description subtests
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.
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months2
Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)
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)
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months3
Change in measure of naming as assessed by Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND)
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).
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 Months4
Change in measure of comprehension as assessed by Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 8, higher score=better outcome.
Time frame
From enrollment to the end of treatment at 5 weeks, 3 Months and 6 MonthsSponsors and contacts
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Source ClinicalTrials.gov