NCT01805336: SEPREV

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

Completed NA Last updated 17 February 2026

What this trial tests

NA trial testing Assessment of attentional functions by traditional tests in Relapsing-Remitting Multiple Sclerosis in 60 participants. Completed in 9 July 2020.

Timeline

28 March 2013

Primary endpoint
9 July 2020

9 July 2020

Quick facts

Lead sponsor	University Hospital, Caen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	other
Enrollment	60
Start date	28 March 2013
Primary completion	9 July 2020
Estimated completion	9 July 2020
Sites	2 locations across France

Drugs / interventions 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

Conditions studied

• Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →

Sponsor

University Hospital, Caen

Who can join

Adults 30 to 60, any sex, with Relapsing-Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.