Status:
COMPLETED
Assessment of Language Disorders in Multiple Sclerosis Patients
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Groupe Hospitalier Pitie-Salpetriere
Saint Antoine University Hospital
Conditions:
Sclerosis
Language Disorders
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Multiple sclerosis (MS) is an autoimmune disease of the central nervous systems that results in focal inflammatory lesions and then diffuse and degenerative inflammatory phenomena. It is considered to...
Detailed Description
Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis. Experimental tasks based on psycholinguistics and functional MRI are not standardized tests. To be able to interpr...
Eligibility Criteria
Inclusion
- Criteria for inclusion of cases :
- Patient with a diagnosis of RRMS or MS according to the Mac Donald criteria 2017
- Patient between 18 and 60 years old inclusive
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
- Patients in structured computerised databases for MS
- Criteria for non-inclusion of cases
- Pregnant or breastfeeding woman
- Patient with a psychological disorder that may induce a language disorder (AHH - anxiety score ≥ 8 or AHH - depression score ≥ 8) (scale in Appendix 11)
- Patient with a history of language impairment before the onset of MS
- Patient receiving speech therapy for language disorders
- Patient whose mother tongue is not French
- Patient with too much dysarthria hindering the intelligibilité́ of his words
- Patient with uncorrected visual and/or hearing impairment
- Neurological diseases (other than MS)
- Psychiatric disorders
- Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
- Criteria for inclusion of witnesses
- Person matched to a "case" on age (+/-3 years) and education level (see Annex 11)
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
- Criteria for non-inclusion of witnesses
- Pregnant or breastfeeding woman
- Psychic disorder that can induce a language disorder (AHH - anxiety score ≥ 8 or AHH - depression score ≥ 8) (Appendix 10)
- History of Language Impairment
- Person receiving speech therapy for language disorders
- Person whose mother tongue is not French
- Person with too much dysarthria hindering the intelligibilité́ of his words
- Uncorrected visual and/or hearing impairment
- Person with a neurological disease
- Psychiatric disorders
- Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker).
Exclusion
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04465084
Start Date
August 17 2020
End Date
July 8 2022
Last Update
February 15 2023
Active Locations (1)
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1
Antoine GUEGUEN
Paris, France