Multiple SclerosisE-SEPNCT04694534
Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
A study testing Serious game and Usual HAS care in people with Multiple Sclerosis and Memory, run by Lille Catholic University at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Memory, Learning
- What is being tested?
- Serious game and Usual HAS care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Oct 2021to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing-remitting or progressive multiple sclerosis people defined according to Mc Donald's criteria revised in 2005
- Age between ≥ 18 and ≤ 65 years old
- Cognitive complaint, with at least one deficient score at the initial neuropsychological examination (<5th percentile of the reference group), one of the scores of which concerns at least one BICAMS test
- Have not had a definite relapse for at least 6 weeks
- Be at least 4 weeks away from a corticosteroid bolus
- Lack of neuroleptic treatment
- Patient with an Internet connection
- Signed informed consent
Who cannot join
- Severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment.
- Neuropsychological care
- Inability to receive oral and written information
- Inability to use the software (due in particular to motor and / or sensory difficulties),
- Neurological or psychiatric comorbidity, other than MS and anxiodepressive syndrome
- Patient with severe anxiodepressive syndrome (BDI> 27)
Show all 9Show fewer
- Participation in an interventional study on cognitive functions
- Patient under legal protection, guardianship or curatorship
- Pregnant or breastfeeding women
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CH Arras
Arras, Hauts-de-France, 62000
Patrick LE COZ, 03 21 21 13 60, Patrick.LE-COZ@ch-arras.fr
Patrick LE COZ
- Recruiting
CH LENS
Lens, Hauts-de-France, 62300
Julien LANNOY, jlannoy@ch-lens.fr
Julien LANNOY
- Recruiting
CHRU
Lille, Hauts-de-France, 59000
Camille Jougleux, 06 09 76 13 29, Caroline.VIE@CHRU-LILLE.FR
Camille Jougleux
- Recruiting
Saint Vincent hospital
Lille, Hauts-de-France, 59000
Bruno Lenne, MD, lenne.bruno@ghicl.net
Bruno Lenne
- Recruiting
Saint-Philibert hospital
Lomme, Nord, 59462
Lansiaux Amélie, MD, PhD, 03.20.22.52.69, lansiaux.amelie@ghicl.net
Moutailler Elodie, 03.20.22.52.69, moutailler.elodie@ghicl.net
- Recruiting
Charles Nicolle Hospital
Rouen, Normandy, 76000
Bertrand Bourre, 02 32 88 33 99, Bertrand.Bourre@chu-rouen.fr
Bertrand Bourre
About this study
Official title: e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Memory, Learning
- Being tested
- Serious game, Usual HAS care
- Keywords
- Multiple sclerosis, Serious game, Episodic memory learning capacities, Information processing speed capacities
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gameDiagnostic test
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.
Usual HAS careDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Remediation program via a "serious game" | Experimental | Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game" Receives: Diagnostic Test: Serious game |
| Classic care (French Haute Autorité de Santé) | Placebo comparator | Classic care (recommended by French Haute Autorité de Santé) Receives: Diagnostic Test: Usual HAS care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 4 and 10 months
Secondary outcomes (20)
Change in the Auditory-verbal spans in direct or reverse order
This assessment is required to evaluate short time memory and working memory.
Measured: 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.
Measured: Change from baseline at 4 and 10 months
Change in the Trail Making Test
This assessment is required to evaluate cognitive flexibility abilities.
Measured: 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.
Measured: Change from baseline at 4 and 10 months
Change in the Tower of London test
This test is required to assess planning capacities.
Measured: 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.
Measured: Change from baseline at 4 and 10 months
Change in the Concentrated Attention Test
This assessment is required to evaluate selective attention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Observance at 4 months
Game session lenght
This outcome is required to evaluate the instructions observance and play practices.
Measured: Observance at 4 months
Time spent gaming
This outcome is required to evaluate the instructions observance and play practices.
Measured: 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.
Measured: 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.
Measured: Observance at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start8 Oct 2021
- Primary completion4 Apr 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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 Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 Control group 1 Experimental group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Lenne, Principal investigator, Hôpital Saint-Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694534
- Sponsor's protocol ID
- RC-P0066
- Acronym
- E-SEP
- Status last verified
- Sep 2025
- First submitted
- 16 Dec 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lenne B, Degraeve B, Davroux J, Norberciak L, Kwiatkowski A, Donze C. Improving cognition in people with multiple sclerosis: study protocol for a multiarm, randomised, blinded trial of multidomain cognitive rehabilitation using a video-serious game (E-SEP cognition). BMJ Neurol Open. 2023 Nov 27;5(2):e000488. doi: 10.1136/bmjno-2023-000488. eCollection 2023.
PubMed 38033375
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial
- ClinicalTrials.gov ID
- NCT04694534
- Acronym / sponsor ID
- E-SEP / RC-P0066
- Conditions
- Multiple Sclerosis, Memory, Learning
- Keywords
- Multiple sclerosis, Serious game, Episodic memory learning capacities, Information processing speed capacities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 4 Apr 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Jan 2021 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1 Control group 1 Experimental group
| Arm | Type | Receives |
|---|---|---|
| Remediation program via a "serious game" | Experimental | Diagnostic Test: Serious gameClassic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game" |
| Classic care (French Haute Autorité de Santé) | Placebo comparator | Diagnostic Test: Usual HAS careClassic care (recommended by French Haute Autorité de Santé) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsing-remitting or progressive multiple sclerosis people defined according to Mc Donald's criteria revised in 2005
- Age between ≥ 18 and ≤ 65 years old
- Cognitive complaint, with at least one deficient score at the initial neuropsychological examination (<5th percentile of the reference group), one of the scores of which concerns at least one BICAMS test
- Have not had a definite relapse for at least 6 weeks
- Be at least 4 weeks away from a corticosteroid bolus
Key exclusion criteria (9 listed)
- Severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment.
- Neuropsychological care
- Inability to receive oral and written information
- Inability to use the software (due in particular to motor and / or sensory difficulties),
- Neurological or psychiatric comorbidity, other than MS and anxiodepressive syndrome
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 |
|---|---|---|
| Serious gameThe 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. | Diagnostic test | Remediation program via a "serious game" |
| Usual HAS careThe 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. | Diagnostic test | Classic care (French Haute Autorité de Santé) |
Primary outcome
Change in the California Verbal Learning Test (CVLT)
Time frame: Change from baseline at 4 and 10 months
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.
Change in the Brief Visuo-spatial Memory Test (BVMT)
Time frame: Change from baseline at 4 and 10 months
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.
Change in the Symbol Digit Modalities Test (SDMT)
Time frame: Change from baseline at 4 and 10 months
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.
20 secondary outcomes
Change in the Auditory-verbal spans in direct or reverse order
Time frame: Change from baseline at 4 and 10 months
Change in the Stroop Color-Word Test
Time frame: Change from baseline at 4 and 10 months
Change in the Trail Making Test
Time frame: Change from baseline at 4 and 10 months
Change in the Categorical and phonemic verbal fluency test
Time frame: Change from baseline at 4 and 10 months
Change in the Tower of London test
Time frame: Change from baseline at 4 and 10 months
Change in the Commission test
Time frame: Change from baseline at 4 and 10 months
Change in the Concentrated Attention Test
Time frame: Change from baseline at 4 and 10 months
Change in the Paced Auditory Serial Addition Task (PASAT)
Time frame: Change from baseline at 4 and 10 months
Change in the Mac Nair Scale
Time frame: Change from baseline at 4 and 10 months
Change in the IPA (Participation and Autonomy Impact) Form
Time frame: Change from baseline at 4 and 10 months
Change in the BDI-II Scale (Beck Depression Inventory II)
Time frame: Change from baseline at 4 and 10 months
Change in the State-Trait Anxiety Inventory (STAI Y)
Time frame: Change from baseline at 4 and 10 months
Change in the Visual Analogue Scale for Fatigue
Time frame: Change from baseline at 4 and 10 months
Change in the Apparent validity
Time frame: Change from baseline at 4 and 10 months
Change in the EDSS score (Expanded disability status scale)
Time frame: Change from baseline at 4 and 10 months
Frequency of game play per Week (in days)
Time frame: Observance at 4 months
Game session lenght
Time frame: Observance at 4 months
Time spent gaming
Time frame: Observance at 4 months
Game performance : tests number per exercise
Time frame: Observance at 4 months
Game performance : difficulty levels
Time frame: Observance at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 38033375Lenne B, Degraeve B, Davroux J, Norberciak L, Kwiatkowski A, Donze C. Improving cognition in people with multiple sclerosis: study protocol for a multiarm, randomised, blinded trial of multidomain cognitive rehabilitation using a video-serious game (E-SEP cognition). BMJ Neurol Open. 2023 Nov 27;5(2):e000488. doi: 10.1136/bmjno-2023-000488. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Bruno Lenne principal investigator
Hôpital Saint-Vincent de Paul
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game and Usual HAS care in people with Multiple Sclerosis and Memory, run by Lille Catholic University at 6 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lausiaux, MD, PhD (03.20.22.52.69, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the California Verbal Learning Test (CVLT) (time frame: Change from baseline at 4 and 10 months). The study lists 3 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 NCT04694534, 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 4 Sep 2025.