Assessment of Language Disorders in Multiple Sclerosis Patients — LANSEP  

Language Disorders Clinical Trial

Official title: Assessment of Language Disorders in Multiple Sclerosis Patients

Status Completed

Clinical Trial 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 be the leading cause of non-traumatic disability in young adults.

Cognitive impairment is a common and disabling part of MS. Studies carried out in the years 1990-2000 estimated their frequency to be between 40 and 60% of MS patients: they reflect the natural history of the disease. Effective treatments for the inflammatory component of the disease that are now available may have led to a reduction in their frequency.

Cognitive disorders were identified at an early stage of the disease and affect certain areas preferentially:

• The most common achievement is the reduction in the speed of information processing. It is present from the early stage of the disease. Progressive deterioration over time is observed, which is a prognostic factor for long-term cognitive decline.

Long-term memory was impaired in 40-65% of patients in historical cohorts. More specifically, encoding and retrieval were affected, with storage and consolidation being preserved.

• The attainment of executive functions is also common.

• Phonemic and semantic fluency are also disturbed in MS patients. Among cognitive impairments, language impairment has been little studied in MS: in 2016 only 22 controlled studies were identified. The assessments carried out were most often partial, making it impossible to define the characteristics or to conclude that specific linguistic impairments are independent of other cognitive impairments. Finally, recent studies suggest that the frequency of language impairment in MS may be underestimated.

Therefore, it seems important to assess the prevalence of language disorders in a large cohort of patients with RRMS or MS, and to characterize these disorders by identifying the linguistic processes involved and the brain substrates involved. This will make it possible to envisage the implementation of more systematic screening for language disorders in MS and to improve patient management, in particular by developing targeted rehabilitation protocols.

Clinical Trial 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 interpret the results of patients, they must therefore be compared with healthy controls of the same age (+/-3 years) and level of education.

This study will require the inclusion of cases and controls matched to these cases on the above characteristics.

Patients who are seen in consultation or day hospitalization and who meet the inclusion and non-inclusion criteria will be offered the opportunity to participate in the study. Accompanying persons accompanying patients "matching" with included patients who meet the inclusion and non-inclusion criteria will also be offered the opportunity to participate in the study.

Inclusion visit (D0) :

• Completion of the HAD self-questionnaire

• Validation of inclusion and exclusion criteria

• Signature of consent

• Collection of socio-demographic data to adjust standardized test results (age, gender, socio-economic and education level)

• Completion of the computerized ECVB self-questionnaire with the help of a clinical research technician: only for cases

• Scheduling of the HDJ assessment day (maximum 6 months after the inclusion visit)

Visit 1 (assessment in HDJ) (D0 + 6 months maximum) :

• Neurological examination of the patient and performance of an EDSS if necessary

• Battery of standardised and normalised tests evaluating different cognitive functions (Annexes 1 and 2 to 9): only for cases

• Experimental language tasks (see description in section 6): for cases and controls

• Non-injected structural and functional encephalic MRI: only for cases with language impairment detected in the examination battery (and their matched controls) ;

Related Conditions & MeSH terms

• Language Disorders
• Multiple Sclerosis
• Sclerosis

• NCT number: NCT04465084
• Study type: Interventional
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Completion date: July 8, 2022