Speech and Language Interventions for Italian People With PPA

NCT ID: NCT06739967

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-08-31

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.

Detailed Description

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.

Conditions

Primary Progressive Aphasia(PPA)

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Speech and Language Therapy; SLT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituti Clinici Scientifici Maugeri IRCCS

Bari, , Italy

Site Status: RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Petronilla Battista, PhD

Role: CONTACT

Phone: +390807814331

Email: petronilla.battista@gbhi.org

Christian Lunetta, MD

Role: CONTACT

Phone: +39 02 5072 5266

Email: christian.lunetta@icsmaugeri.it

Facility Contacts

Petronilla Battista, PhD

Role: primary

Christian Lunetta, MD

Role: backup

Federica Agosta, MD, PhD

Role: primary

Elisa Canu, PhD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 26062526 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 20139998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29718131 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3324947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31358572 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36636857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21325651 (View on PubMed)

Other Identifiers

PNRR-MCNT2-2023-12378220

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1767/CEL

Identifier Type: -

Identifier Source: org_study_id