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Trial record 2 of 4 for:    071102

Early Cognitive Impairment in Multiple Sclerosis (CogniSEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157728
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 31, 2012
ARSEP (Association pour la Recherche sur la Sclerose en Plaques)
JNLF (Journées de Neurologie de Langue Française)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Cognitive impairment is one of the symptoms of Multiple Sclerosis (MS), and it may occur during the first years of the disease. It usually affects attention, information processing speed and short term memory. To date, the mechanisms of this specific symptom remain unclear (local or global inflammation, neurodegenerative processes).

Magnetic Resonance Imaging (MRI) can be useful to understand the pathophysiology of cognitive impairment in MS. The investigators will combine conventional and non conventional MRI sequences to determine the respective role of white matter and grey matter injury and the cortical reorganization of neuronal networks.

Condition or disease
Multiple Sclerosis Cognitive Impairment

Detailed Description:

Cognitive impairment in Multiple Sclerosis (MS) occurs in 50% of patients and has a major social impact. There is no clear correlation between cognitive dysfunction and disease duration and recent studies have pointed out that it may affects patients at the very early stages of the disease especially in tasks involving sustained attention, processing speed, working memory and executive function.

Recent imaging and pathology studies have shown that MS affects white matter as well as grey matter. Unlike white matter lesion burden or distribution, grey matter atrophy has often been linked to cognitive impairment. Microscopic injury of Normally Appearing White Matter (NAWM) explored by non conventional MRI sequences has also been shown to be involved in pathophysiology of cognitive disorders.

Nevertheless mechanisms of cognitive impairment remain unclear. The relationship between cortical injury and diffuse white matter tracts damage and their respective contribution to cognitive dysfunction affecting patients during the first years of the disease is still under investigation.

This study aims at investigating structural and functional correlates of early cognitive impairment using multimodal MRI.

Relapsing Remitting MS (RRMS) patients with disease duration of less than 5 years will be included. Patients with and without cognitive impairment will be compared to healthy controls. All subjects will perform a clinical and neuropsychological evaluation before the MRI examination.

We will combine new available MRI techniques using a 3 Tesla magnet in order to evaluate precisely cortical and white matter tracts lesions in patients with cognitive MS. These techniques will include :

  • 3D T1 sequences to study cortical atrophy using VBM.
  • Diffusion tensor imaging fibre tracking to study selected white matter tracts that may be involved in cognitive disorders, such as the thalamus-cortical or the striatum-cortical tracts connecting sub-cortical structures to the prefrontal cortex.
  • Functional MRI sequences during a working memory task and during the resting state in order to describe functional networks and their possible reorganization in patients with or without cognitive impairment.

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury
Study Start Date : May 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Relapsing Multiple Sclerosis patients
healthy volunteer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Relapsing remitting Multiple Sclerosis patients
  • Age: 18-40 years
  • Evolving between 3 and 5 years
  • EDSS<5

Inclusion Criteria:

  • Relapsing remitting Multiple Sclerosis patients
  • Age: 18-40 years
  • Evolving between 3 and 5 years
  • EDSS<5

Exclusion Criteria:

  • MRI exclusion criteria (metallic prothetic, pace maker etc)
  • Renal failure due to Gadolinium injection
  • Major depressive disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157728

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Pitie salpêtrière Hospital
PAris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ARSEP (Association pour la Recherche sur la Sclerose en Plaques)
JNLF (Journées de Neurologie de Langue Française)
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Principal Investigator: Bruno Stankoff, MD,PhD Pitié-Salpêtrière Hospital
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01157728    
Other Study ID Numbers: P071102
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: May 2010
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multiple sclerosis
Cognitive impairment
Additional relevant MeSH terms:
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Multiple Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders