SclerosisLANSEPNCT04465084
Assessment of Language Disorders in Multiple Sclerosis Patients
A study testing Case and Withness in people with Sclerosis and Language Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Language Disorders
- What is being tested?
- Case and Withness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2020to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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)
- Conditions
- Sclerosis, Language Disorders
- Being tested
- Case, Withness
- Medical subject headings
- Sclerosis, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseOther
Battery of standardised and normalised tests evaluating different cognitive functions Experimental language tasks MRI
WithnessOther
Experimental language tasks MRI
| Study group | Role | What they receive |
|---|---|---|
| Case | Other | Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis. Receives: Other: Case |
| Witness | Other | Person matched to a "case" on age (+/-3 years) and education level Receives: Other: Withness |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion de patient with language disorders in patients with RRMS or MS
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start17 Aug 2020
- Primary completion17 Aug 2020
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Saint Antoine University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465084
- Sponsor's protocol ID
- AGN_2020-18
- Acronym
- LANSEP
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2020
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Language Disorders in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04465084
- Acronym / sponsor ID
- LANSEP / AGN_2020-18
- Conditions
- Sclerosis, Language Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Saint Antoine University Hospital
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis.
| Arm | Type | Receives |
|---|---|---|
| Case | Other | Other: CaseRelapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis. |
| Witness | Other | Other: WithnessPerson matched to a "case" on age (+/-3 years) and education level |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaseBattery of standardised and normalised tests evaluating different cognitive functions Experimental language tasks MRI | Other | Case |
| WithnessExperimental language tasks MRI | Other | Witness |
Primary outcome
proportion de patient with language disorders in patients with RRMS or MS
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case and Withness in people with Sclerosis and Language Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion de patient with language disorders in patients with RRMS or MS (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.