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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

— SEPREV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805336
• Other study ID #: 2012-A000000166-37
• Secondary ID: 12-027
• Status: Completed
• Phase: N/A
• Start date: March 28, 2013
• Est. completion date: July 9, 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

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).
• 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.
• 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.
• Assessment of executive functions by virtual reality test
For assessment of executive functions, virtual reality test include : VAP-S.
• 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.

Locations

Country	Name	City	State
France	Department of Neurologie, Caen Hospital University	Caen	Basse-Normandie
France	Inserm Unit 1075 Comete, Caen Hospital University	Caen	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores for traditional tests	For each test, scores will be compared between patients and healthy subjects.	2 visits over 1 week
Primary	Scores for virtual reality tests	For each test, scores will be compared between patients and healthy subjects.	2 visits over 1 week
Primary	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.	2 visits over 1 week
Primary	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.	2 visits over 1 week
Secondary	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.	Inclusion visit
Secondary	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.	inclusion visit