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NCT03455582

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-09-24

Completion Date

2026-03

Last Updated

2026-02-03

Healthy Volunteers

Yes

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)

Inclusion Criteria: PATIENTS * Male or female; * Age ≥ 18 years; * PPMS diagnosis according to McDonald 2010 criteria; * Disease duration ≤ 15 years; * Native French speaking; * Being affiliated to health insurance; * Willing to participate and to sign informed consent. HEALTHY CONTROLS * Male or Female; * Age ≥ 18 years; * Native French speaking; * Being affiliated to health insurance; * Willing to participate and to sign informed consent. Exclusion Criteria: PATIENTS * previous history of other neurological disease; * psychiatric comorbidity including severe depression according to DSM-IV; * alcohol or other addiction to toxic; * disabling visual or motor problems preventing participation to neuropsychological assessments; * change of psychotropic drug since less than one month; * contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body,claustrophobia or refusing MRI); * illiteracy, is unable to count or to read; * pregnant or breastfeeding women; * patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent). HEALTHY CONTROLS * history of neurological disease; * family history of MS; * psychiatric comorbidity including severe depression according to DSM-IV; * alcohol or other toxic addiction; * psychotropic drugs; known cognitive complaint or neuropsychological affection; * prior neuropsychological testing with the same tests less than 6 months * contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, meta fragments or foreign objects in the eyes, skin or body, claustrophobia or refusing MRI); * illiteracy, is unable to count or to read; * pregnant or breastfeeding women; * person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

Locations (3)

CHU de Bordeaux

Bordeaux, France

CHU de Limoges

Limoges, France

CHU de Poitiers

Poitiers, France

Clinical Research Directory

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (3)