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

NCT ID: NCT01805336

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-28
• Study Completion Date: 2020-07-09

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Assessment of attentional functions by traditional tests

Intervention Type: OTHER

For assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT).

Assessment of attentional functions by virtual reality tests

Intervention Type: OTHER

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.

Assessment of executive functions by traditional tests

Intervention Type: OTHER

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.

Assessment of executive functions by virtual reality test

Intervention Type: OTHER

For assessment of executive functions, virtual reality test include : VAP-S.

Evaluation of cognitive complaint, fatigue, anxiety and depression

Intervention Type: OTHER

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 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.

Group Type: OTHER

Assessment of attentional functions by traditional tests

Intervention Type: OTHER

For assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT).

Assessment of attentional functions by virtual reality tests

Intervention Type: OTHER

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.

Assessment of executive functions by traditional tests

Intervention Type: OTHER

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.

Assessment of executive functions by virtual reality test

Intervention Type: OTHER

For assessment of executive functions, virtual reality test include : VAP-S.

Evaluation of cognitive complaint, fatigue, anxiety and depression

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Assessment of executive functions by virtual reality test

For assessment of executive functions, virtual reality test include : VAP-S.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Defer, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Department of Neurologie, Caen Hospital University

Caen, Basse-Normandie, France

Inserm Unit 1075 Comete, Caen Hospital University

Caen, Basse-Normandie, France

Countries

France

Other Identifiers

12-027

Identifier Type: OTHER

Identifier Source: secondary_id

2012-A000000166-37

Identifier Type: -

Identifier Source: org_study_id