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

  • STATUS
    Recruiting
  • End date
    Mar 21, 2025
  • participants needed
    80
  • sponsor
    University Hospital, Bordeaux
Updated on 21 April 2022
Accepts healthy volunteers

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.

Details
Condition Multiple Sclerosis, Primary Progressive
Treatment neuropsychological evaluation, clinical assessment, MRI evaluation, Psychological evaluation, Ecological evaluation
Clinical Study IdentifierNCT03455582
SponsorUniversity Hospital, Bordeaux
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

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)
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