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

NCT01805336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-17

No results posted yet for this study

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

  • Relapsing-Remitting Multiple Sclerosis

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Gilles Defer, Professor · University Hospital, Caen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-28
Primary Completion
2020-07-09
Completion
2020-07-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805336 on ClinicalTrials.gov