Cognition Evolution and MRI Markers in PPMS Patients on 2 Years (PRO-COG)

University Hospital of Bordeaux

Status: Active, not recruiting

Conditions: Multiple Sclerosis, Primary Progressive

Treatments: Device: MRI Evaluation; Other: Ecological evaluation; Other: Clinical assessment; Other: Neuropsychological evaluation; Other: Psychological evaluation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03455582

CHUBX 2017/14

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

patient

Experimental group

Description:

PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)

Treatment:

Other: Psychological evaluation

Other: Neuropsychological evaluation

Other: Clinical assessment

Other: Ecological evaluation

Device: MRI Evaluation

Control

Active Comparator group

Description:

40 Healthy controls

Treatment:

Other: Psychological evaluation

Other: Neuropsychological evaluation

Other: Ecological evaluation

Device: MRI Evaluation