Trials / Completed
CompletedNCT01865357
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- University Hospital, Bordeaux · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
Detailed description
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Brain MRI - Clinical and cognitive evaluation | * Clinical evaluation (EDSS, MSFC) * Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59) * Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI |
| OTHER | Eye movement | Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months |
Timeline
- Start date
- 2012-08-24
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2013-05-30
- Last updated
- 2018-10-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01865357. Inclusion in this directory is not an endorsement.