NCT01865357: SCI-COG

Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI

Completed NA Last updated 3 October 2018

What this trial tests

NA trial testing Brain MRI - Clinical and cognitive evaluation in Clinically Isolated Demyelinating Syndromes in 117 participants. Completed in 1 December 2016.

Timeline

24 August 2012

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	117
Start date	24 August 2012
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	1 location across France

Drugs / interventions tested

• Brain MRI - Clinical and cognitive evaluation
• Eye movement

Conditions studied

• Clinically Isolated Demyelinating Syndromes — all drugs for Clinically Isolated Demyelinating Syndromes →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Cognitive Deficiencies — all drugs for Cognitive Deficiencies →
• Brain MRI — all drugs for Brain MRI →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Clinically Isolated Demyelinating Syndromes or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regional hippocampal vulnerability in early multiple sclerosis: Dynamic pathological spreading from dentate gyrus to CA1.
   Planche V, Koubiyr I, Romero JE, Manjon JV, et al · · 2018 · cited 46× · PMID 29331060 · DOI 10.1002/hbm.23970
2. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis.
   Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, et al · · 2017 · cited 44× · PMID 27789541 · DOI 10.1136/jnnp-2016-313867
3. Pattern separation performance is decreased in patients with early multiple sclerosis.
   Planche V, Ruet A, Charré-Morin J, Deloire M, et al · · 2017 · cited 16× · PMID 28828205 · DOI 10.1002/brb3.739
4. Differential Gray Matter Vulnerability in the 1 Year Following a Clinically Isolated Syndrome.
   Koubiyr I, Deloire M, Coupé P, Dulau C, et al · · 2018 · cited 10× · PMID 30364223 · DOI 10.3389/fneur.2018.00824
5. Microstructural analyses of the posterior cerebellar lobules in relapsing-onset multiple sclerosis and their implication in cognitive impairment.
   Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, et al · · 2017 · cited 8× · PMID 28792528 · DOI 10.1371/journal.pone.0182479
6. Insights on the Relationship Between Hippocampal Connectivity and Memory Performances at the Early Stage of Multiple Sclerosis.
   Boscheron J, Ruet A, Deloire M, Charré-Morin J, et al · · 2021 · cited 6× · PMID 34093415 · DOI 10.3389/fneur.2021.667531