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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity Hospital of Mont-Godinne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

progressive forms of MS

Trial design

Design model

Single group

Treatments tested in this trial

  • Multiparametric assessment

    Other intervention

    neuropsychological assessment, PRO measures, non-conventional MRI metrics

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: RRMS patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

Predictors of disease evolution

EDSS score worsening from baseline

Time frame
3 years
2

evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline

changes from baseline in cognitive scores

Time frame
3 years
3

baseline predictors of future cognitive impairment

abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)

Time frame
3 years

Secondary outcomes

1

alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment

fractional anisotropy

Time frame
3 years
2

predictive role of mEPS in predicting future disability

the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Mont-Godinne

Lead sponsor

Saint-Luc University Hospital

Collaborator