SEPREVAssessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Assessment of attentional functions by traditional tests
+ Assessment of attentional functions by virtual reality tests
+ Assessment of executive functions by traditional tests
Maladies Auto-immunes+9
+ Troubles Mentaux
+ Troubles de la cognition
Autre étude
Résumé
Date de début de l'étude : 28 mars 2013
Date à laquelle le premier participant a commencé l'étude.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 significant socio-professional burden. Today assessment of cognitive dysfunction in MS is still based on traditional pencil-paper task tests which are not able to give a true representation of functional burden observed in patients in real life situations. The development of new tools close to these "life situations", i.e. more ecological, are needed to better assess and take in charge cognitive impairment in MS patients. One way to reach this goal is Virtual Reality (VR). VR offers a new human-computer interface paradigm that simulates a realistic 3D environment where the user become immersed and interacts with it. These last ten years VR has known a rapid development in the health domain and has been applied with success to motor rehabilitation, psychiatry and neuropsychology. In this last domain, virtual environment (VE) reproducing activities of daily living have been used to evaluate executive and memory functions as well as attentional or visuospatial processes. Among main VE developed, driving assessment system, navigation skills, cooking behaviors, virtual supermarket have shown better sensitivity to detect functional consequences of cognitive impairment in various neurological and psychiatric disorders than traditional evaluations. In Caen University Hospital, investigators used VE driving system and developed the use of the Virtual Action Planning in a supermarket (VAP-S ; Klinger et al 2004) where a user move to select and buy groceries and other things inside an interactive virtual supermarket using a shopping cart. In a preliminary study investigators have used this virtual interactive tool to evaluate executive functioning in small group of Parkinson's disease and MS patients. Analysis of initial data shows the feasibility of the VAP-S for use with these two kinds of diseases. According to these results investigators planned a new study in Relapsing-Remitting(RR)- MS patients where they compare the use of VE (driving system and the VAP-S) to traditional attentional and executive evaluation for estimate their respective sensitivity to detect cognitive/functional impairment in MS patients. Investigators hope to shown that VR will demonstrate its interest to assess cognitive functions in MS and to develop cognitive rehabilitation.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 30 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: 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 Criteria: 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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Groupe II
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Department of Neurologie, Caen Hospital University
Caen, FranceOuvrir Department of Neurologie, Caen Hospital University dans Google MapsInserm Unit 1075 Comete, Caen Hospital University
Caen, France