NCT03455582

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2018-09-24
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2018-03-06
• Last updated: 2026-02-03

Locations

3 sites across 1 country: France