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

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT01805336

Collaborator

(none)

Enrollment

Locations

Arms

87.4

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-Remitting Multiple Sclerosis	Other: Assessment of attentional functions by traditional tests Other: Assessment of attentional functions by virtual reality tests Other: Assessment of executive functions by traditional tests Other: Assessment of executive functions by virtual reality test Other: Evaluation of cognitive complaint, fatigue, anxiety and depression	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 28, 2013

Actual Primary Completion Date :

Jul 9, 2020

Actual Study Completion Date :

Jul 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm A 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.	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.
Other: Arm B 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.	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.

Arm

Intervention/Treatment

Other: Arm A

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.

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.

Other: Arm B

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.

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

Other: Assessment of executive functions by traditional tests

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

Outcome Measures

Primary Outcome Measures

Scores for traditional tests [2 visits over 1 week]
For each test, scores will be compared between patients and healthy subjects.
Scores for virtual reality tests [2 visits over 1 week]
For each test, scores will be compared between patients and healthy subjects.
Correlation between traditional and virtual reality tests [2 visits over 1 week]
Links between scores for traditional tests and scores for virtual reality tests will assessed by calculating Pearson or Spearman correlation coefficents, among all participants.
Z-scores for traditional and virtual reality tests [2 visits over 1 week]
For each patient and each score, z-score will be calculated. For traditional and virtual reality tests for which a correlation will be observed, the z-scores will be compared.

Secondary Outcome Measures

Score for cognitive complaint questionnaire [Inclusion visit]
Correlation coefficients will be calculated between scores for cognitive complaint questionnaire and scores for virtual reality tests, among all participants.
Scores for fatigue, anxiety and depression questionnaires [inclusion visit]
Correlation coefficients will be calculated between scores for fatigue, anxiety and depression questionnaires and scores for traditional and virtual reality tests, among all participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurologie, Caen Hospital University	Caen	Basse-Normandie	France	14033
2	Inserm Unit 1075 Comete, Caen Hospital University	Caen	Basse-Normandie	France	14033