Cognition Evolution and MRI Markers in PPMS Patients on 2 Years
NCT ID: NCT03455582
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
66 participants
INTERVENTIONAL
2018-09-24
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Clinical assessment
Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.
Ecological evaluation
Virtual reality task and Actual reality
Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Psychological evaluation
questionnaires for depression, anxiety and fatigue
MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)
Control
40 Healthy controls
Ecological evaluation
Virtual reality task and Actual reality
Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Psychological evaluation
questionnaires for depression, anxiety and fatigue
MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)
Interventions
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Clinical assessment
Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.
Ecological evaluation
Virtual reality task and Actual reality
Neuropsychological evaluation
cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
Psychological evaluation
questionnaires for depression, anxiety and fatigue
MRI Evaluation
morphological MRI and resting state functional MRI (fMRI)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
Yes
Sponsors
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Roche Pharma AG
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Aurélie RUET, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU de Bordeaux
Bordeaux, , France
CHU de Limoges
Limoges, , France
CHU de Poitiers
Poitiers, , France
Countries
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Other Identifiers
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CHUBX 2017/14
Identifier Type: -
Identifier Source: org_study_id
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