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Recruiting NCT04957537

Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

No phase Interventional Primary Progressive Aphasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: semantic therapy and semantic re-education.
Who it may be relevant to
Registry conditions: Primary Progressive Aphasia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 bas

Primary outcome measures

  • Performance in speaking [Time frame: Baseline (before phase A)]
  • Performance in speaking [Time frame: Baseline (before phase A)]
  • Performance in speaking [Time frame: immediately after the intervention (after phase B)]
  • Performance in speaking [Time frame: immediately after the intervention (after phase B)]
Secondary outcome measures (1)
  • Maintenance of the performance in speaking [Time frame: 1 month after the end of the intervention (after phase B)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Toulouse — Toulouse

Identifiers

NCT: NCT04957537 · RC31/21/0215

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗