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

Multiple Sclerosis Clinical Trial

— E-SEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694534
• Other study ID #: RC-P0066
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2023
• Source: Lille Catholic University
• Contact: Amélie Lausiaux, MD, PhD
• Phone: 03.20.22.52.69
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Learning
• Memory
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CH d'Arras	Arras	Nord Pas De Calais
France	CH LENS	Lens	Nord Pas De Calais
France	CHRU	Lille	Nord Pas De Calais
France	Saint Vincent hospital	Lille	Nord Pas De Calais
France	Saint-Philibert hospital	Lomme	Nord
France	Charles Nicolle Hospital	Rouen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 4 and 10 months
Primary	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.	Change from baseline at 4 and 10 months
Primary	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.	Change from baseline at 4 and 10 months
Secondary	Change in the Auditory-verbal spans in direct or reverse order	This assessment is required to evaluate short time memory and working memory.	Change from baseline at 4 and 10 months
Secondary	Change in the Stroop Color-Word Test	This assessment is required to evaluate inhibition capacities and sensitivity to interference.	Change from baseline at 4 and 10 months
Secondary	Change in the Trail Making Test	This assessment is required to evaluate cognitive flexibility abilities.	Change from baseline at 4 and 10 months
Secondary	Change in the Categorical and phonemic verbal fluency test	This test is required to evaluate the spontaneous flexibility abilities.	Change from baseline at 4 and 10 months
Secondary	Change in the Tower of London test	This test is required to assess planning capacities.	Change from baseline at 4 and 10 months
Secondary	Change in the Commission test	This test assesses planning skills in a greener context than the Tower of London test.	Change from baseline at 4 and 10 months
Secondary	Change in the Concentrated Attention Test	This assessment is required to evaluate selective attention.	Change from baseline at 4 and 10 months
Secondary	Change in the Paced Auditory Serial Addition Task (PASAT)	This assessment is required to evaluate information processing speed and sustained attention.	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	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).	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	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.	Change from baseline at 4 and 10 months
Secondary	Frequency of game play per Week (in days)	This outcome is required to evaluate the instructions observance and play practices.	Observance at 4 months
Secondary	Game session lenght	This outcome is required to evaluate the instructions observance and play practices.	Observance at 4 months
Secondary	Time spent gaming	This outcome is required to evaluate the instructions observance and play practices.	Observance at 4 months
Secondary	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.	Observance at 4 months
Secondary	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.	Observance at 4 months