A phase IV, unicentric, open label clinical trial to evaluate the default mode network in multiple sclerosis patients on Cladribine treatment.

Conditions

Multiple Sclerosis

Brief summary

Changes in resting state functional activity indexes (rs-fMRI) at 18 months compared to baseline

Detailed description

Changes in resting state functional activity indexes (rs-fMRI) after 18 months of cladribine treatment, Changes in Image Tensor Diffusion of main cerebral tracts after 18 months of cladribine treatment., Changes in volumetric measures from key brain region (corpus callosum, thalamus and hippocampus) after 18 months of cladribine treatment, The contribution of cortico-cerebellar connectivity to MS cognitive performance after 18 months of cladribine treatment, Changes in cortical Atrophy Index after 18 months of cladribine treatment after 18 months of cladribine treatment., Changes in Brain Activity during processing speed task after 18 months of cladribine treatment., Changes in cognitive functioning indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in emotional/behavioural indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in clinical neurological status measured with EDSS and ARR after 18 months of cladribine treatment.

Related papers

No related papers found yet.

Interventions

DRUGMAVENCLAD 10 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Changes in resting state functional activity indexes (rs-fMRI) at 18 months compared to baseline	—

Secondary

Measure	Time frame
Changes in resting state functional activity indexes (rs-fMRI) after 18 months of cladribine treatment, Changes in Image Tensor Diffusion of main cerebral tracts after 18 months of cladribine treatment., Changes in volumetric measures from key brain region (corpus callosum, thalamus and hippocampus) after 18 months of cladribine treatment, The contribution of cortico-cerebellar connectivity to MS cognitive performance after 18 months of cladribine treatment, Changes in cortical Atrophy Index after 18 months of cladribine treatment after 18 months of cladribine treatment., Changes in Brain Activity during processing speed task after 18 months of cladribine treatment., Changes in cognitive functioning indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in emotional/behavioural indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in clinical neurological status measured with EDSS and ARR after 18 mont	—

Measure

Time frame

Changes in resting state functional activity indexes (rs-fMRI) after 18 months of cladribine treatment, Changes in Image Tensor Diffusion of main cerebral tracts after 18 months of cladribine treatment., Changes in volumetric measures from key brain region (corpus callosum, thalamus and hippocampus) after 18 months of cladribine treatment, The contribution of cortico-cerebellar connectivity to MS cognitive performance after 18 months of cladribine treatment, Changes in cortical Atrophy Index after 18 months of cladribine treatment after 18 months of cladribine treatment., Changes in Brain Activity during processing speed task after 18 months of cladribine treatment., Changes in cognitive functioning indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in emotional/behavioural indexes measured with neuropsychological tests after 18 months of cladribine treatment., Changes in clinical neurological status measured with EDSS and ARR after 18 mont

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Countries

Spain

Outcome results

None listed