Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

Primary Progressive Aphasia Clinical Trial

— SCED-APPvs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957537
• Other study ID #: RC31/21/0215
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Jérémie PARIENTE, MD PhD
• Phone: 0561777686
• Email: pariente.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

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).

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)