An interventional study of Serious game and Usual HAS care in Multiple Sclerosis, Memory and Learning, sponsored by Lille Catholic University. Recruiting at 6 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic
Among 18 studies in Multiple Sclerosis by Lille Catholic University — 5 open to participants now, 5 under way, none of them phase 3. Multiple Sclerosis · Lille Catholic University.
Among the 18 studies in Multiple Sclerosis by Lille Catholic University, this one is the 2nd largest by planned enrollment of the 11 interventional ones that give a count, is one of 3 that started in 2021, is one of 11 with no phase, and was the 11th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →5 of the 18 studies in Multiple Sclerosis by Lille Catholic University are open now, in 1 country. Recruiting first, the newest first:
Lille Catholic University · Sites in France
Lille Catholic University · Sites in France
Lille Catholic University · Sites in France
Lille Catholic University
By country, each count listing its studies:
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2021.
This study's planned enrollment of 150 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Median enrollment 46 across the 11 interventional studies, 153 across the 7 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Multiple Sclerosis by Lille Catholic University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.
Cognitive impairment affects 40 to 70% multiple sclerosis patients. This condition is characterized by slower information processing, associated with deficits in episodic memory, attention and executive functions. These disorders appear early, regardless of functional impairment, in "benign" forms and in clinically isolated syndromes of multiple sclerosis. These disruptions can have a significant impact in the socio-professional and personal life of patients and also in the quality of life (job loss risks, daily activities limitations).
Even if these disorders are now well documented, remediation strategies remain less studied. Some studies show that the "training" methods, often used, do not seem suitable for clinical monitoring, with benefits that do not persist over time. Despite their impact on daily life, no specific care for planning abilities, mental inhibition and flexibility, or even social cognition, have been well studied until today. The same is true concerning metacognitive abilities. Finally, remedial techniques are time consuming and difficult to adapt to patients still in professional activity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game"
Diagnostic Test: Serious game
Classic care (recommended by French Haute Autorité de Santé)
Diagnostic Test: Usual HAS care
The serious game is accessible via an online platform, on a tablet: 4 20-minutes activities sessions per week must be carried out. The program format in the serious game form makes possible to simultaneously understand a large number of cognitive functions.
The control group patients will follow the care they need, according to the HAS recommendations. Non-specific cognitive activities notebooks will be provided to them. They will be instructed to perform the 4 20-minutes sessions per week for 4 months.
Change in the California Verbal Learning Test (CVLT)
The California Verbal Learning Test (CVLT) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible.
Time frame: Change from baseline at 4 and 10 months
Change in the Brief Visuo-spatial Memory Test (BVMT)
In the Brief Visuospatial/lMemory Test six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12.
Time frame: Change from baseline at 4 and 10 months
Change in the Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure: the number correct.
Time frame: Change from baseline at 4 and 10 months
Change in the Auditory-verbal spans in direct or reverse order
This assessment is required to evaluate short time memory and working memory.
Time frame: Change from baseline at 4 and 10 months
Change in the Stroop Color-Word Test
This assessment is required to evaluate inhibition capacities and sensitivity to interference.
Time frame: Change from baseline at 4 and 10 months
Change in the Trail Making Test
This assessment is required to evaluate cognitive flexibility abilities.
Time frame: Change from baseline at 4 and 10 months
Change in the Categorical and phonemic verbal fluency test
This test is required to evaluate the spontaneous flexibility abilities.
Time frame: Change from baseline at 4 and 10 months
Change in the Tower of London test
This test is required to assess planning capacities.
Time frame: Change from baseline at 4 and 10 months
Change in the Commission test
This test assesses planning skills in a greener context than the Tower of London test.
Time frame: Change from baseline at 4 and 10 months
Change in the Concentrated Attention Test
This assessment is required to evaluate selective attention.
Time frame: Change from baseline at 4 and 10 months
Change in the Paced Auditory Serial Addition Task (PASAT)
This assessment is required to evaluate information processing speed and sustained attention.
Time frame: Change from baseline at 4 and 10 months
Change in the Mac Nair Scale
This self-evaluation is required to assess cognitive complaint. It is a 39-items questionnaire corresponding to symptoms. Every symptom is noted on an ordinal scale in 5 steps.It is a scale with 5 degrees of severity measuring the frequency of disorders as follows: 4 = very often, 3 = often, 2 = sometimes, 1 = rarely, 0 = never.
Time frame: Change from baseline at 4 and 10 months
Change in the IPA (Participation and Autonomy Impact) Form
This test is focused on the subject social participation and autonomy. is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The standard cut-off scores are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Time frame: Change from baseline at 4 and 10 months
Change in the BDI-II Scale (Beck Depression Inventory II)
This scale is required to assess participants depressive orders. This is a 21-items self-questionnaire. Every item is rated from 0 (no problem) to 3 (maximum symptom severity). The depressive syndrome severity total score presents 4 intensity levels : 0-11 (no depression), 12-19 (mild depression), 20-27 (medium depression), 27 (severe depression).
Time frame: Change from baseline at 4 and 10 months
Change in the State-Trait Anxiety Inventory (STAI Y)
This scale is used to evaluate the participants level anxiety. It is a 20-items questionnaire. The patients identifie the frequency with which they usually feel the symptoms listed on a four-point Likert-type scale variant from 1: "never" on the 1 point side to 4: "always" on the 4 point side. The overall score varies between 20 and 80.
Time frame: Change from baseline at 4 and 10 months
Change in the Visual Analogue Scale for Fatigue
This scale allows patients to assess their fatigue. The patients locate their fatigue intensity on a 100-millimeters horizontal line.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: Change from baseline at 4 and 10 months
Change in the Apparent validity
Face validity is based on a subjective assessment of the instrument's validity to assess the patient's attitude towards the tool, its degree of involvement and its acceptability.
Time frame: Change from baseline at 4 and 10 months
Change in the EDSS score (Expanded disability status scale)
This score is required to assess the patients functional and neurological level disability. This scale stretchs from 0 (no complaint and normal examen) to 10 (death caused by MS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Time frame: Change from baseline at 4 and 10 months
Frequency of game play per Week (in days)
This outcome is required to evaluate the instructions observance and play practices.
Time frame: Observance at 4 months
Game session lenght
This outcome is required to evaluate the instructions observance and play practices.
Time frame: Observance at 4 months
Time spent gaming
This outcome is required to evaluate the instructions observance and play practices.
Time frame: Observance at 4 months
Game performance : tests number per exercise
This outcome is required to evaluate the instructions observance and play practices. The performance will be evaluated by the tests number per exercise.
Time frame: Observance at 4 months
Game performance : difficulty levels
This outcome is required to evaluate the instructions observance and play practices. The performance will be evaluated by the difficulty levels.
Time frame: Observance at 4 months
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Apr 2026, 53 months after the start.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 53 months is above that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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