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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of attentional functions by traditional tests
Assessment of attentional functions by virtual reality tests
Assessment of executive functions by traditional tests
Assessment of executive functions by virtual reality test
Evaluation of cognitive complaint, fatigue, anxiety and depression
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Relapsing-Remitting MS, cognitive impairment, virtual reality

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neurologie, Caen Hospital University
  • Inserm Unit 1075 Comete, Caen Hospital University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Scores for traditional tests
For each test, scores will be compared between patients and healthy subjects.
Scores for virtual reality tests
For each test, scores will be compared between patients and healthy subjects.
Correlation between traditional and virtual reality tests
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
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
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
Correlation coefficients will be calculated between scores for fatigue, anxiety and depression questionnaires and scores for traditional and virtual reality tests, among all participants.

Full Information

First Posted
February 26, 2013
Last Updated
February 25, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT01805336
Brief Title
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Acronym
SEPREV
Official Title
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
July 9, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
Relapsing-Remitting MS, cognitive impairment, virtual reality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Other
Arm Description
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.
Arm Title
Arm B
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of attentional functions by traditional tests
Intervention Description
For assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT).
Intervention Type
Other
Intervention Name(s)
Assessment of attentional functions by virtual reality tests
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of executive functions by traditional tests
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Assessment of executive functions by virtual reality test
Intervention Description
For assessment of executive functions, virtual reality test include : VAP-S.
Intervention Type
Other
Intervention Name(s)
Evaluation of cognitive complaint, fatigue, anxiety and depression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores for traditional tests
Description
For each test, scores will be compared between patients and healthy subjects.
Time Frame
2 visits over 1 week
Title
Scores for virtual reality tests
Description
For each test, scores will be compared between patients and healthy subjects.
Time Frame
2 visits over 1 week
Title
Correlation between traditional and virtual reality tests
Description
Links between scores for traditional tests and scores for virtual reality tests will assessed by calculating Pearson or Spearman correlation coefficents, among all participants.
Time Frame
2 visits over 1 week
Title
Z-scores for traditional and virtual reality tests
Description
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.
Time Frame
2 visits over 1 week
Secondary Outcome Measure Information:
Title
Score for cognitive complaint questionnaire
Description
Correlation coefficients will be calculated between scores for cognitive complaint questionnaire and scores for virtual reality tests, among all participants.
Time Frame
Inclusion visit
Title
Scores for fatigue, anxiety and depression questionnaires
Description
Correlation coefficients will be calculated between scores for fatigue, anxiety and depression questionnaires and scores for traditional and virtual reality tests, among all participants.
Time Frame
inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Defer, Professor
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurologie, Caen Hospital University
City
Caen
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
Inserm Unit 1075 Comete, Caen Hospital University
City
Caen
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

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

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