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Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS (COGNIT-MS)

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ClinicalTrials.gov Identifier: NCT05510817
Recruitment Status : Recruiting
First Posted : August 22, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
Saint-Luc University Hospital
Information provided by (Responsible Party):
Frédéric London, University Hospital of Mont-Godinne

Brief Summary:
This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Other: Multiparametric assessment Not Applicable

Detailed Description:

Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.

The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).

The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.

Yearly assessment starting from study inclusion will be performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : June 6, 2026
Estimated Study Completion Date : June 6, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
RRMS patients
RRMS patients initiating a new DMT
Other: Multiparametric assessment
neuropsychological assessment, PRO measures, non-conventional MRI metrics




Primary Outcome Measures :
  1. Predictors of disease evolution [ Time Frame: 3 years ]
    EDSS score worsening from baseline

  2. evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline [ Time Frame: 3 years ]
    changes from baseline in cognitive scores

  3. baseline predictors of future cognitive impairment [ Time Frame: 3 years ]
    abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)


Secondary Outcome Measures :
  1. alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment [ Time Frame: 3 years ]
    fractional anisotropy

  2. predictive role of mEPS in predicting future disability [ Time Frame: 3 years ]
    the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • active MS, according to the Lublin criteria
  • disease duration < 10 years before initiating or changing a disease-modifying therapies,
  • relapse- and steroid-free for at least 1 month before MRI acquisition
  • between 18-50 years old
  • having given informed consent
  • with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances

Exclusion Criteria:

  • progressive forms of MS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05510817


Contacts
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Contact: Frédéric London, MD +3282413345 frederic.london@chuuclnamur.uclouvain.be

Locations
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Belgium
CHU UCL Namur site Godinne Recruiting
Yvoir, Namur, Belgium
Contact: Frédéric London, MD    +3281423345    frederic.london@chuuclnamur.uclouvain.be   
Sponsors and Collaborators
University Hospital of Mont-Godinne
Saint-Luc University Hospital
Investigators
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Principal Investigator: Frédéric London, MD University Hospital Mont-Godinne
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Responsible Party: Frédéric London, Principal Investigator, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT05510817    
Other Study ID Numbers: B039202042775
First Posted: August 22, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frédéric London, University Hospital of Mont-Godinne:
MRI
evoked potentials
cognitive function
PROMs
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases