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NCT Number: NCT04957537

Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semantic therapy and semantic re-education

Behavioral

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).

Primary outcomes

  1. Performance in speaking

    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.

  2. Performance in speaking

    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.

  3. Performance in speaking

    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.

  4. Performance in speaking

    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.

Secondary outcomes

  1. Maintenance of the performance in speaking

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jérémie PARIENTE, MD PhD

CONTACT

[email protected]

0561777686

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: SCED-APPvs

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2021
Registry last updated
Aug 2, 2024

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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