Semantic Rehabilitation for Patients With Primary Progressive Semantic Aphasia

NCT04957537 | Recruiting

• 1 other identifier: RC31/21/0215
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (before phase A)

• 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.

  Baseline (before phase A)

• 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.

  immediately after the intervention (after phase B)

• 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.

  immediately after the intervention (after phase B)

Secondary Outcomes (1)

• Maintenance of the performance in speaking

  1 month after the end of the intervention (after phase B)

Study Arms (2)

6 weeks phase A

OTHER

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.

Behavioral: semantic therapy and semantic re-education

8 weeks phase A

OTHER

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.

Behavioral: semantic therapy and semantic re-education

Interventions

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).

6 weeks phase A; 8 weeks phase A

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive; Pick Disease of the Brain; Communication Disorders; Anomia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Neurodevelopmental Disorders

Study Officials

• Jérémie PARIENTE, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie PARIENTE, MD PhD

CONTACT

0561777686; pariente.j@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: September 20, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)