Clinical trial NCT04957537: Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Progressive Aphasia
Keywords: Semantic primary progressive aphasia
semantic variant (svPPA)
speech therapy
anomia
metacognition
Single Case Experimental Design
technology
naming
speed of lexical access
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, monocentric, prospective, randomised, controlled research. Single Case Experimental Design" type study in multiple baselines with 2 successive phases (A-B design) for each patient. For each subject, phase A constitutes the baseline (6 to 8 weeks), phase B is characterised by semantic rehabilitation (5 weeks). The beginning of the intervention will be sequential and the duration of the baseline will be randomised for each patient.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Performance in speaking
timeFrame: Baseline (before phase A)
measure: Performance in speaking
timeFrame: Baseline (before phase A)
measure: Performance in speaking
timeFrame: immediately after the intervention (after phase B)
measure: Performance in speaking
timeFrame: immediately after the intervention (after phase B)
Secondary outcomes:
measure: Maintenance of the performance in speaking
timeFrame: 1 month after the end of the intervention (after phase B)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Jérémie PARIENTE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: