Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

Not Applicable

Recruiting

• Conditions: Primary Progressive Aphasia
• Interventions: Behavioral: semantic therapy and semantic re-education

• Registration Number: NCT04957537
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-12
• Study Start: 2021-09-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8 weeks phase A	semantic therapy and semantic re-education	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.
6 weeks phase A	semantic therapy and semantic re-education	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.

Primary Outcome Measures

Name	Time	Method
Performance in speaking	immediately after the intervention (after phase B)	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.

Secondary Outcome Measures

Name	Time	Method
Maintenance of the performance in speaking	1 month after the end of the intervention (after phase B)	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).

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France