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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.
 
ClinicalTrials.gov Identifier: NCT01157728
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 31, 2012
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

Tracking Information
First Submitted Date July 6, 2010
First Posted Date July 7, 2010
Last Update Posted Date July 31, 2012
Study Start Date May 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Cognitive Impairment in Multiple Sclerosis
Official Title Early Cognitive Impairment in Multiple Sclerosis: a Multimodal MRI Study Evaluating the Relative Contribution of Cortical and White Matter Tract Injury
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • Relapsing remitting Multiple Sclerosis patients
  • Age: 18-40 years
  • Evolving between 3 and 5 years
  • EDSS<5
Condition
  • Multiple Sclerosis
  • Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts
  • Relapsing Multiple Sclerosis patients
  • healthy volunteer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2012)
69
Original Estimated Enrollment
 (submitted: July 6, 2010)
60
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01157728
Other Study ID Numbers P071102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators
  • ARSEP (Association pour la Recherche sur la Sclerose en Plaques)
  • JNLF (Journées de Neurologie de Langue Française)
Investigators
Principal Investigator: Bruno Stankoff, MD,PhD Pitié-Salpêtrière Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2010