CHU Toulouse
Toulouse, France
Location status: Recruiting
NCT Number: NCT04957537
This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Toulouse, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Baseline (before phase A)
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.
Time frame: Baseline (before phase A)
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.
Time frame: immediately after the intervention (after phase B)
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.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Evaluation of the Effect of a Semantic Rehabilitation in Patients in the Mild to Moderate Stage of Primary Progressive Semantic Aphasia : a SCED Study
Acronym: SCED-APPvs
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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