Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

Официальное название

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

Обзор

This project aims to measure the effect of a semantic rehabilitation protocol for patients with primary progressive semantic aphasia and using the SCED methodology.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Performance in speaking [Срок оценки: Baseline (before phase A)]
• Performance in speaking [Срок оценки: Baseline (before phase A)]
• Performance in speaking [Срок оценки: immediately after the intervention (after phase B)]
• Performance in speaking [Срок оценки: immediately after the intervention (after phase B)]

Вторичные конечные точки (1)

• Maintenance of the performance in speaking [Срок оценки: 1 month after the end of the intervention (after phase B)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU Toulouse — Toulouse

Идентификаторы

NCT: NCT04957537 · RC31/21/0215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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