Trials / Completed
CompletedNCT01805336
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- University Hospital, Caen · Academic / Other
- Sex
- All
- Age
- 30 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Assessment of attentional functions by traditional tests | For assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT). |
| OTHER | Assessment of attentional functions by virtual reality tests | For assessment of attentional functions, virtual reality tests include : Monotonous task of driving on motorways, Task of city driving with accident scenarios, Monotonous driving task with divided attention test ; all tests realized on a driving simulator. |
| OTHER | Assessment of executive functions by traditional tests | For assessment of executive functions, traditional tests include : Wisconsin Card Sorting Test (WCST), Task verbal fluencies, Sequence Numbers Letters subtest of the Wechsler Adult Intelligence Scale (WAIS) III, Commissions. |
| OTHER | Assessment of executive functions by virtual reality test | For assessment of executive functions, virtual reality test include : VAP-S. |
| OTHER | Evaluation of cognitive complaint, fatigue, anxiety and depression | The following questionnaires will be completed by the participant at the inclusion visit : cognitive complaint RBN-SEP questionnaire to assess cognitive complaint, EMIF-SEP to assess fatigue, STAI (State Trait Anxiety Inventory) to assess anxiety and MADRS to assess depression. |
Timeline
- Start date
- 2013-03-28
- Primary completion
- 2020-07-09
- Completion
- 2020-07-09
- First posted
- 2013-03-06
- Last updated
- 2026-02-17
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01805336. Inclusion in this directory is not an endorsement.