Relapsing-Remitting Multiple SclerosisSEPREVNCT01805336
Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
A study testing Assessment of attentional functions by traditional tests, Assessment of attentional functions by virtual reality tests and Assessment of executive functions by traditional tests in people with Relapsing-Remitting Multiple Sclerosis, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Assessment of attentional functions by traditional tests, Assessment of attentional functions by virtual reality tests and Assessment of executive functions by traditional tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Mar 2013to 9 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Neurologie, Caen Hospital University
Caen, Basse-Normandie, 14033
Inserm Unit 1075 Comete, Caen Hospital University
Caen, Basse-Normandie, 14033
About this study
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
- Being tested
- 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
- Keywords
- Relapsing-Remitting MS, cognitive impairment, virtual reality
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of attentional functions by traditional testsOther
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 testsOther
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 testsOther
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 testOther
For assessment of executive functions, virtual reality test include : VAP-S.
Evaluation of cognitive complaint, fatigue, anxiety and depressionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | 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. Receives: 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 |
| Arm B | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores for traditional tests
For each test, scores will be compared between patients and healthy subjects.
Measured: 2 visits over 1 week
Scores for virtual reality tests
For each test, scores will be compared between patients and healthy subjects.
Measured: 2 visits over 1 week
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.
Measured: 2 visits over 1 week
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.
Measured: 2 visits over 1 week
Secondary outcomes (2)
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.
Measured: Inclusion visit
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.
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start28 Mar 2013
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Defer, Professor, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805336
- Sponsor's protocol ID
- 2012-A000000166-37
- Other IDs
- 12-027
- Acronym
- SEPREV
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2013
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Delsanti R, Le Mercier E, Briant A, Derache N, Arnaud C, Branger P, Defer G. Can a virtual reality tool detect minor executive functions impairment in patients with multiple sclerosis? Rev Neurol (Paris). 2025 Sep;181(7):681-690. doi: 10.1016/j.neurol.2025.06.009. Epub 2025 Jul 23.
PubMed 40707327
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Attentional and Executive Disorders in Multiple Sclerosis Using Techniques of Virtual Reality
- ClinicalTrials.gov ID
- NCT01805336
- Acronym / sponsor ID
- SEPREV / 2012-A000000166-37
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Relapsing-Remitting MS, cognitive impairment, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | 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 depressionInclusion : 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 B | Other | 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 depressionInclusion : 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients only :
- Patients and healthy subjects :
Key exclusion criteria (13 listed)
- Patients only :
- Patients and healthy subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of attentional functions by traditional testsFor assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT). | Other | Arm A, Arm B |
| Assessment of attentional functions by virtual reality testsFor 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 | Arm A, Arm B |
| Assessment of executive functions by traditional testsFor 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 | Arm A, Arm B |
| Assessment of executive functions by virtual reality testFor assessment of executive functions, virtual reality test include : VAP-S. | Other | Arm A, Arm B |
| Evaluation of cognitive complaint, fatigue, anxiety and depressionThe 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 A, Arm B |
Primary outcome
Scores for traditional tests
Time frame: 2 visits over 1 week
For each test, scores will be compared between patients and healthy subjects.
Scores for virtual reality tests
Time frame: 2 visits over 1 week
For each test, scores will be compared between patients and healthy subjects.
Correlation between traditional and virtual reality tests
Time frame: 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
Time frame: 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.
2 secondary outcomes
Score for cognitive complaint questionnaire
Time frame: Inclusion visit
Scores for fatigue, anxiety and depression questionnaires
Time frame: inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 40707327Delsanti R, Le Mercier E, Briant A, Derache N, Arnaud C, Branger P, Defer G. Can a virtual reality tool detect minor executive functions impairment in patients with multiple sclerosis? Rev Neurol (Paris). 2025 Sep;181(7):681-690. doi: 10.1016/j.neurol.2025.06.009. Epub 2025 Jul 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Defer, Professor principal investigator
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of attentional functions by traditional tests, Assessment of attentional functions by virtual reality tests and Assessment of executive functions by traditional tests in people with Relapsing-Remitting Multiple Sclerosis, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores for traditional tests (time frame: 2 visits over 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.