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Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia (SCED-APPvs)

Primary Purpose

Primary Progressive Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
semantic therapy and semantic re-education
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring Semantic primary progressive aphasia, semantic variant (svPPA), speech therapy, anomia, metacognition, Single Case Experimental Design, technology, naming, speed of lexical access

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

6 weeks phase A

8 weeks phase A

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 22, 2021
Last Updated
July 10, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04957537
Brief Title
Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia
Acronym
SCED-APPvs
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 weeks phase A
Arm Type
Other
Arm Description
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.
Arm Title
8 weeks phase A
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
semantic therapy and semantic re-education
Intervention Description
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 Outcome Measure Information:
Title
Performance in speaking
Description
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)
Title
Performance in speaking
Description
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)
Title
Performance in speaking
Description
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)
Title
Performance in speaking
Description
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)
Secondary Outcome Measure Information:
Title
Maintenance of the performance in speaking
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémie PARIENTE, MD PhD
Phone
0561777686
Email
pariente.j@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérémie PARIENTE, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Pariente, MD, PhD
Phone
05.61.77.95.02
Email
pariente.j@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

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