Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

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

CompletedNot a drug-phase studyProgressive MSNCT03455582

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Clinical assessment

Given to everyone in the trial

  • Ecological evaluation
  • Neuropsychological evaluation
  • Psychological evaluation
  • MRI Evaluation

What it measured

Main measures

  • Change of composite z cognitive score based on individual neuropsychological scores

    At baseline (day 0) and at 24 months from baseline

    Thinking and memory

Other measures (3)

  • Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity

    At baseline (day 0) and at 24 months from baseline

    MRI lesionsThinking and memoryNerve conduction tests

  • Change of composite z cognitive score based on individual neuropsychological scores

    At baseline (day 0), at 12 months and at 24 months from baseline

    Thinking and memory

  • Changes of composite z ecological score based on individual ecological scores

    At baseline (day 0), at 12 months and at 24 months from baseline

    Thinking and memory

Who could take part

Progressive MS · 18 and over

Show the full criteria

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).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Sept 2018

    2. Main results due

      Apr 2026

    3. Finished

      Apr 2026

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