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Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients (E-SEP)

Primary Purpose

Multiple Sclerosis, Memory, Learning

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game
Usual HAS care
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Serious game, Episodic memory learning capacities, Information processing speed capacities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH d'Arras
  • CH LENS
  • CHRURecruiting
  • Saint Vincent hospitalRecruiting
  • Saint-Philibert hospitalRecruiting
  • Charles Nicolle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remediation program via a "serious game"

Classic care (French Haute Autorité de Santé)

Arm Description

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

Classic care (recommended by French Haute Autorité de Santé)

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2020
Last Updated
June 21, 2023
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04694534
Brief Title
Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Memory, Learning
Keywords
Multiple sclerosis, Serious game, Episodic memory learning capacities, Information processing speed capacities

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 Control group 1 Experimental group
Masking
Outcomes Assessor
Masking Description
This is a blinded study for neuropsychological assessment.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remediation program via a "serious game"
Arm Type
Experimental
Arm Description
Classic care (recommended by the French Haute Autorité de Santé) accompanied by cognitive remediation by "serious game"
Arm Title
Classic care (French Haute Autorité de Santé)
Arm Type
Placebo Comparator
Arm Description
Classic care (recommended by French Haute Autorité de Santé)
Intervention Type
Diagnostic Test
Intervention Name(s)
Serious game
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Usual HAS care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the California Verbal Learning Test (CVLT)
Description
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
Title
Change in the Brief Visuo-spatial Memory Test (BVMT)
Description
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
Title
Change in the Symbol Digit Modalities Test (SDMT)
Description
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
Secondary Outcome Measure Information:
Title
Change in the Auditory-verbal spans in direct or reverse order
Description
This assessment is required to evaluate short time memory and working memory.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Stroop Color-Word Test
Description
This assessment is required to evaluate inhibition capacities and sensitivity to interference.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Trail Making Test
Description
This assessment is required to evaluate cognitive flexibility abilities.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Categorical and phonemic verbal fluency test
Description
This test is required to evaluate the spontaneous flexibility abilities.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Tower of London test
Description
This test is required to assess planning capacities.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Commission test
Description
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
Title
Change in the Concentrated Attention Test
Description
This assessment is required to evaluate selective attention.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Paced Auditory Serial Addition Task (PASAT)
Description
This assessment is required to evaluate information processing speed and sustained attention.
Time Frame
Change from baseline at 4 and 10 months
Title
Change in the Mac Nair Scale
Description
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
Title
Change in the IPA (Participation and Autonomy Impact) Form
Description
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
Title
Change in the BDI-II Scale (Beck Depression Inventory II)
Description
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
Title
Change in the State-Trait Anxiety Inventory (STAI Y)
Description
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
Title
Change in the Visual Analogue Scale for Fatigue
Description
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
Title
Change in the Apparent validity
Description
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
Title
Change in the EDSS score (Expanded disability status scale)
Description
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
Title
Frequency of game play per Week (in days)
Description
This outcome is required to evaluate the instructions observance and play practices.
Time Frame
Observance at 4 months
Title
Game session lenght
Description
This outcome is required to evaluate the instructions observance and play practices.
Time Frame
Observance at 4 months
Title
Time spent gaming
Description
This outcome is required to evaluate the instructions observance and play practices.
Time Frame
Observance at 4 months
Title
Game performance : tests number per exercise
Description
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
Title
Game performance : difficulty levels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Lausiaux, MD, PhD
Phone
03.20.22.52.69
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Moutailler
Phone
03.20.22.52.69
Email
moutailler.elodie@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Lenne
Organizational Affiliation
Hôpital Saint-Vincent de Paul
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Arras
City
Arras
State/Province
Nord Pas De Calais
ZIP/Postal Code
62000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LE COZ
Phone
03 21 21 13 60
Email
Patrick.LE-COZ@ch-arras.fr
First Name & Middle Initial & Last Name & Degree
Patrick LE COZ
Facility Name
CH LENS
City
Lens
State/Province
Nord Pas De Calais
ZIP/Postal Code
62300
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Jougleux
Phone
06 09 76 13 29
Email
Caroline.VIE@CHRU-LILLE.FR
First Name & Middle Initial & Last Name & Degree
Camille Jougleux
Facility Name
Saint Vincent hospital
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Lenne, MD
Email
lenne.bruno@ghicl.net
First Name & Middle Initial & Last Name & Degree
Bruno Lenne
First Name & Middle Initial & Last Name & Degree
Julien Poupart
First Name & Middle Initial & Last Name & Degree
Arnaud Kwiatkowski
Facility Name
Saint-Philibert hospital
City
Lomme
State/Province
Nord
ZIP/Postal Code
59462
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lansiaux Amélie, MD, PhD
Phone
03.20.22.52.69
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name & Degree
Moutailler Elodie
Phone
03.20.22.52.69
Email
moutailler.elodie@ghicl.net
First Name & Middle Initial & Last Name & Degree
Bruno Lenne, MD
First Name & Middle Initial & Last Name & Degree
Cécile Donzé, MD
Facility Name
Charles Nicolle Hospital
City
Rouen
State/Province
Normandie
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Bourre
Phone
02 32 88 33 99
Email
Bertrand.Bourre@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Bertrand Bourre

12. IPD Sharing Statement

Plan to Share IPD
No

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

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