Speech and Language Interventions for Italian People With PPA

NCT06739967 | Recruiting DMC

• 2 other identifiers: 1767/CELPNRR-MCNT2-2023-12378220
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary Progressive Aphasia(PPA)

Keywords

Speech and language therapy; online intervention; Frontotemporal dementia; Alzheimer's disease; PPA; Communication Disorders; Neurodegenerative Diseases; Dementia

Outcome Measures

Primary Outcomes (4)

• 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)

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

• Change in number of articulatory and grammatical errors

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

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

• 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.

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

• Change on untrained probes within each clinical variant

  Number of untrained items correctly identified

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

Secondary Outcomes (24)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

Speech and Language Tailored Interventions

Patients will receive three days a week for 5 weeks of 45 minute sessions of a tailored speech and language intervention

Behavioral: Behavioral Treatment

Interventions

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.

Also known as: Speech and Language Therapy, SLT

Speech and Language Tailored Interventions

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary progressive aphasia.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (2)

Istituti Clinici Scientifici Maugeri IRCCS

Bari, 70124, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (7)

• Tippett DC, Hillis AE, Tsapkini K. Treatment of Primary Progressive Aphasia. Curr Treat Options Neurol. 2015 Aug;17(8):362. doi: 10.1007/s11940-015-0362-5.

  PMID: 26062526 BACKGROUND

• Grossman M. Primary progressive aphasia: clinicopathological correlations. Nat Rev Neurol. 2010 Feb;6(2):88-97. doi: 10.1038/nrneurol.2009.216.

  PMID: 20139998 BACKGROUND

• Henry 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: 29718131 BACKGROUND

• Mesulam MM. Primary progressive aphasia--differentiation from Alzheimer's disease. Ann Neurol. 1987 Oct;22(4):533-4. doi: 10.1002/ana.410220414. No abstract available.

  PMID: 3324947 BACKGROUND

• Volkmer A, Rogalski E, Henry M, Taylor-Rubin C, Ruggero L, Khayum R, Kindell J, Gorno-Tempini ML, Warren JD, Rohrer JD. Speech and language therapy approaches to managing primary progressive aphasia. Pract Neurol. 2020 Apr;20(2):154-161. doi: 10.1136/practneurol-2018-001921. Epub 2019 Jul 29.

  PMID: 31358572 BACKGROUND

• Battista P, Piccininni M, Montembeault M, Messina A, Minafra B, Miller BL, Henry ML, Gorno Tempini ML, Grasso SM. Access, referral, service provision and management of individuals with primary progressive aphasia: A survey of speech-language therapists in Italy. Int J Lang Commun Disord. 2023 Jul-Aug;58(4):1046-1060. doi: 10.1111/1460-6984.12843. Epub 2023 Jan 13.

  PMID: 36636857 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Aphasia, Primary Progressive; Communication Disorders; Frontotemporal Dementia; Neurodegenerative Diseases; Dementia

Interventions

Behavior Therapy; Speech Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neurodevelopmental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Petronilla Battista, PhD

CONTACT

+390807814331; petronilla.battista@gbhi.org

Christian Lunetta, MD

CONTACT

+39 02 5072 5266; christian.lunetta@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)