Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04465084
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2020-07-02
Brief Title:
Assessment of Language Disorders in Multiple Sclerosis Patients
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Assessment of Language Disorders in Multiple Sclerosis Patients
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LANSEP
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
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None