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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03455582
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Bordeaux
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Aurélie RUET, Prof
Principal Investigator Affiliation	CHU Bordeaux
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Primary Progressive

Arms & Interventions

Arms

Experimental: patient

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

Active Comparator: Control

40 Healthy controls

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.