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SEPREVAssessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Assessment of attentional functions by traditional tests

+ Assessment of attentional functions by virtual reality tests

+ Assessment of executive functions by traditional tests

Otro
Quiénes están siendo reclutados

Enfermedades Autoinmunes+4

+ Trastornos Mentales

+ Trastornos Cognitivos

De 30 a 60 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: marzo de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity Hospital, Caen
Última actualización: 17 de febrero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 28 de marzo de 2013

Fecha en la que se inscribió al primer participante.

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.

Patrocinador PrincipalUniversity Hospital, Caen
Última actualización: 17 de febrero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 60 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 30 a 60 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades AutoinmunesTrastornos MentalesTrastornos CognitivosEnfermedades DesmielinizantesEnfermedades del sistema inmunitarioEsclerosis MúltipleEnfermedades del sistema nervioso

Criterios

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 Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by traditional tests + executive function by virtual reality tests. One week later, Assessment 2 : attentional function by virtual reality tests + executive function by traditional tests.

Grupo II

Inclusion : cognitive complaint,fatigue, anxiety an depression questionnaires. Assessment 1 : attentional function by virtual reality tests + executive function by traditional tests. One week later, Assessment 2 : attentional function by traditional tests + executive function by virtual reality tests.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Department of Neurologie, Caen Hospital University

Caen, FranceAbrir Department of Neurologie, Caen Hospital University en Google Maps

Inserm Unit 1075 Comete, Caen Hospital University

Caen, France
Completado2 Centros de Estudio