Status:
COMPLETED
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Lead Sponsor:
University Hospital, Caen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
Since many years cognitive disorders are a main topic of clinical research in Multiple Sclerosis (MS) as there could be observed early on in the disease and could induce with time in patients signific...
Eligibility Criteria
Inclusion
- Patients only :
- Diagnosis of RR-MS in accordance with the Polman et al. criteria (2011)
- Expanded Disability Status Scale (EDSS) \< 6
- Any disease duration
- Patients and healthy subjects :
- Men and women
- Ages 30-60 years inclusive
- Score of \> 130 on the Mattis Dementia Rating Scale (DRS)
- Score of \< 15 on the Montgomery and Asberg Depression Rating Scale (MADRS)
- French native language
- Licensed drivers (\> 2 years)
- Experienced drivers (\> 5000 km / year)
- Normal or corrected visual acuity greater than or equal to 6/10
- Sign informed consent
Exclusion
- Patients only :
- Any relapse or corticosteroids therapy within 30 days
- Under guardianship
- Patients and healthy subjects
- Other neurological, psychiatric or developmental disease
- Serious systemic disease
- Sequelae of brain injury
- Antidepressants or anxiolytics treatment within 4 weeks
- Treatment known to interfere with cognition (e.g. psychostimulant) within 3 months
- Alcohol \> 28 units / week
- Addiction
- Cognitive assessment within a year (including all or part of the assessment proposed in this study)
- Sensory or motor failure incompatible with study tasks
Key Trial Info
Start Date :
March 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01805336
Start Date
March 28 2013
End Date
July 9 2020
Last Update
March 1 2021
Active Locations (2)
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1
Department of Neurologie, Caen Hospital University
Caen, Basse-Normandie, France, 14033
2
Inserm Unit 1075 Comete, Caen Hospital University
Caen, Basse-Normandie, France, 14033