An interventional study of semantic therapy and semantic re-education in Primary Progressive Aphasia, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.
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.
77 studies on the registry are indexed under Aphasia, Primary Progressive; 29 are open to participants now.
This study's planned enrollment of 15 is below the median of 30 across 60 interventional studies indexed under Aphasia, Primary Progressive.
Browse Aphasia, Primary Progressive studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: immediately after the intervention (after phase B)
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).
Time frame: 1 month after the end of the intervention (after phase B)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Mar 2027, 66 months after the start.
Of 38 non-industry interventional studies with no phase under Aphasia, Primary Progressive, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 59. This study's planned 66 months is above that.
Counting every sponsor, half of 38 studies reached it within 41 months; a quarter within 26 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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