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Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

NCT ID: NCT05510817

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2026-06-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Keywords

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MRI evoked potentials cognitive function PROMs

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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RRMS patients

RRMS patients initiating a new DMT

Group Type OTHER

Multiparametric assessment

Intervention Type OTHER

neuropsychological assessment, PRO measures, non-conventional MRI metrics

Interventions

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Multiparametric assessment

neuropsychological assessment, PRO measures, non-conventional MRI metrics

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Luc University Hospital

UNKNOWN

Sponsor Role collaborator

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Frédéric London

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frédéric London, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Mont-Godinne

Locations

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CHU UCL Namur site Godinne

Yvoir, Namur, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Frédéric London, MD

Role: CONTACT

Phone: +3282413345

Email: [email protected]

Facility Contacts

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Frédéric London, MD

Role: primary

Other Identifiers

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B039202042775

Identifier Type: -

Identifier Source: org_study_id