Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Summary

Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.

Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.

Conditions

• Multiple Sclerosis, Primary Progressive

Interventions

OTHER

Clinical assessment

Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.

OTHER

Ecological evaluation

Virtual reality task and Actual reality

OTHER

Neuropsychological evaluation

cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function

OTHER

Psychological evaluation

questionnaires for depression, anxiety and fatigue

DEVICE

MRI Evaluation

morphological MRI and resting state functional MRI (fMRI)

Sponsors & Collaborators

• Roche Pharma AG

  collaborator INDUSTRY

• University Hospital, Bordeaux

  lead OTHER

Principal Investigators

• Aurélie RUET, Prof · University Hospital, Bordeaux

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-24

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• France

Study Locations