Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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) - Participation in an interventional study on cognitive functions.

- Patient under legal protection, guardianship or curatorship.

- Pregnant or breastfeeding women

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04694534
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lille Catholic University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bruno Lenne
Principal Investigator Affiliation	Hôpital Saint-Vincent de Paul
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Memory, Learning

Additional Details

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.

Arms & Interventions

Arms

Experimental: Remediation program via a "serious game"

Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game"

Placebo Comparator: Classic care (French Haute Autorité de Santé)

Classic care (recommended by French Haute Autorité de Santé)

Interventions

Diagnostic Test: - Serious game

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.

Diagnostic Test: - Usual HAS care

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.