Early Cognitive Impairment in Multiple Sclerosis (CogniSEP)

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01157728
First received: July 6, 2010
Last updated: July 30, 2012
Last verified: May 2010
  Purpose

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
Multiple Sclerosis
Cognitive Impairment

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 69
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Relapsing Multiple Sclerosis patients
healthy volunteer

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157728

Locations
France
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)
Investigators
Principal Investigator: Bruno Stankoff, MD,PhD Hôpital de la Salpétrière
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01157728     History of Changes
Other Study ID Numbers: P071102
Study First Received: July 6, 2010
Last Updated: July 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multiple sclerosis
Cognitive impairment

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Cognition Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014