Clinical trial NCT01805336: Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Official title: Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Relapsing-Remitting MS
cognitive impairment
virtual reality
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Scores for traditional tests
timeFrame: 2 visits over 1 week
measure: Scores for virtual reality tests
timeFrame: 2 visits over 1 week
measure: Correlation between traditional and virtual reality tests
timeFrame: 2 visits over 1 week
measure: Z-scores for traditional and virtual reality tests
timeFrame: 2 visits over 1 week
Secondary outcomes:
measure: Score for cognitive complaint questionnaire
timeFrame: Inclusion visit
measure: Scores for fatigue, anxiety and depression questionnaires
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Caen
country: France
facility: Department of Neurologie, Caen Hospital University
state: Basse-Normandie
city: Caen
country: France
facility: Inserm Unit 1075 Comete, Caen Hospital University
state: Basse-Normandie
Study officials:
affiliation: University Hospital, Caen
name: Gilles Defer, Professor
role: PRINCIPAL_INVESTIGATOR
References: