Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia (SCED-APPvs)

Evaluation of the Effect of a Semantic Rehabilitation in Patients in the Mild to Moderate Stage of Primary Progressive Semantic Aphasia : a SCED Study

This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.

Study Overview

• Status: Recruiting
• Conditions: Primary Progressive Aphasia
• Intervention / Treatment: Behavioral: semantic therapy and semantic re-education

Detailed Description

The damage on the semantic system is at the heart of the clinical picture of semantic primary progressive aphasia (PPA), a neuro-evolutionary pathology. In other words, patients gradually lose access to concepts, general knowledge, word memory and meaning. In the absence of effective pharmacological treatment to reduce the symptoms evoked by patients and improve their quality of life, the arguments in favour of speech and language therapy are multiplying.

Numerous lexico-semantic multimodal indication therapies have been described in scientific studies. The most studied is semantic rehabilitation through the analysis of semantic features, which has shown its effectiveness in the context of vascular and post-traumatic aphasia.

However, there are only few studies and applications in neuro-evolutionary pathologies such as semantic PPA and those studies are complicated by methodological biases. It has been shown that relearned knowledge is more likely to be retained and transferred to everyday life (generalisation) if the material used is specific to the needs of each individual. Given the heterogeneity of clinical profiles in neuro-evolving pathologies and the inter-individual variability, the personalised approach should be favoured.

To evaluate the effect of semantic therapy in patients with semantic PPA, this study therefore proposes to use the SCED (Single Case Experimental Design) methodology. In addition to allowing an individual analysis, this methodology has the advantage of corresponding to a high level of evidence due to the acquisition of repeated measures and the randomisation of the introduction of the treatment.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérémie PARIENTE, MD PhD; Phone Number: 0561777686; Email: pariente.j@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Jérémie Pariente, MD, PhD; Phone Number: 05.61.77.95.02; Email: pariente.j@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a diagnosis of primary progressive semantic aphasia according to the criteria of Gorno-Tempini et al (2011) (Appendix A)
• Being in the mild to moderate stage of dementia (MMSE score between 10 and 28) (Crum et al., 1993; Derouesné et al., 1999)
• Common French
• Being affiliated to a social security scheme
• Being over the age of 18 years old

Exclusion Criteria:

• Have significant uncorrected visual and/or hearing impairment
• Have a history of brain injuries, major head trauma
• Have untreated psychiatric disorders
• Have significant motor and/or comprehension problems that make it impossible to take part in the study
• Chronical use of drugs and/or alcohol
• Under guardians or curators
• Severe depression (Beck's depression scale score > 9) (Beck & al., 1961)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 6 weeks phase A; According to SCED methodology design : Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 weeks (i.e. 18 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week.	Behavioral: semantic therapy and semantic re-education; Patients will be followed over two periods "Phase A (randomized, 6 to 8 weeks) - Phase B (5 weeks)". Phase A : Baseline Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 to 8 weeks (i.e. 18 to 24 sessions) depending on the randomisation, at the rate of 3 speech therapy sessions of 45 minutes per week. Phase B : Semantic re-education The sessions will consist of training based on the analysis of semantic traits (Coustaut, 2019). This phase will last 5 weeks (i.e. 15 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. In accordance with the application of the SCED methodology, repeated measurements will be carried out every second session during phases A and B. They will consist of proposing the oral naming task (lasting 10 minutes).
Other: 8 weeks phase A; According to SCED methodology design : Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 8 weeks (i.e. 24 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week.	Behavioral: semantic therapy and semantic re-education; Patients will be followed over two periods "Phase A (randomized, 6 to 8 weeks) - Phase B (5 weeks)". Phase A : Baseline Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 to 8 weeks (i.e. 18 to 24 sessions) depending on the randomisation, at the rate of 3 speech therapy sessions of 45 minutes per week. Phase B : Semantic re-education The sessions will consist of training based on the analysis of semantic traits (Coustaut, 2019). This phase will last 5 weeks (i.e. 15 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week. In accordance with the application of the SCED methodology, repeated measurements will be carried out every second session during phases A and B. They will consist of proposing the oral naming task (lasting 10 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance in speaking	To evaluate speaking accuracy, the study team will assess the number of correct items recovered by the patient when performing a specific naming task before the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.	Baseline (before phase A)
Performance in speaking	To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task before the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.	Baseline (before phase A)
Performance in speaking	To evaluate speaking accuracy, the study team will assess the number of correct items repeated by the patient when performing a specific naming task after the rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.	immediately after the intervention (after phase B)
Performance in speaking	To evaluate speaking response time, the study team will assess the rate at which items are recovered by the patient when performing a specific naming task after rehabilitation. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol.	immediately after the intervention (after phase B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of the performance in speaking	Number of correct items recovered by the patient when performing a specific naming task 1 month after the end of the intervention. The naming task is a selection of 80 items developped by Coustaut in 2019 in its MetaLex protocol. This will be compared to the number of items correctly recovered at the end of the rehabilitation (corresponding to outcome 3 here).	1 month after the end of the intervention (after phase B)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jérémie PARIENTE, MD PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: technology; speech therapy; metacognition; Single Case Experimental Design; anomia; naming; Semantic primary progressive aphasia; semantic variant (svPPA); speed of lexical access
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: RC31/21/0215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No