Assessment of Language Disorders in Multiple Sclerosis Patients

NCT04465084 | Completed

• 1 other identifier: AGN_2020-18
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sclerosis; Language Disorders

Outcome Measures

Primary Outcomes (1)

• proportion de patient with language disorders in patients with RRMS or MS

  6 month

Study Arms (2)

Case

OTHER

Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis.

Other: Case

Witness

OTHER

Person matched to a "case" on age (+/-3 years) and education level

Other: Withness

Interventions

Case OTHER

Battery of standardised and normalised tests evaluating different cognitive functions Experimental language tasks MRI

Case

Withness OTHER

Experimental language tasks MRI

Witness

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator
• Saint Antoine University Hospital: collaborator

Study Sites (1)

Antoine GUEGUEN

Paris, France

Location

MeSH Terms

Conditions

Sclerosis; Language Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 9, 2020
• Study Start: August 17, 2020
• Primary Completion: August 17, 2020
• Study Completion: July 8, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)