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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

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

Clinical Trial Finder

Search Results

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.

International Sites

CHU de Bordeaux, Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux

Bordeaux, ,

Site Contact

Aurelie RUET, Prof

[email protected]

05 56 79 55 21 #+33

CHU de Limoges, Limoges, France

Status

Recruiting

Address

CHU de Limoges

Limoges, ,

Site Contact

Laurent MAGY, Prof

[email protected]

05 56 79 55 21

CHU de Poitiers, Poitiers, France

Status

Recruiting

Address

CHU de Poitiers

Poitiers, ,

Site Contact

Jean-Philippe NEAU, Prof

[email protected]

05 56 79 55 21

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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