NCT04694534

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
10mo left

Started Oct 2021

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2021Mar 2027

First Submitted

Initial submission to the registry

December 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

December 16, 2020

Last Update Submit

September 3, 2025

Conditions

Multiple SclerosisMemoryLearning

Keywords

Multiple sclerosisSerious gameEpisodic memory learning capacitiesInformation processing speed capacities

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (20)

  • Change in the Auditory-verbal spans in direct or reverse order

    Change from baseline at 4 and 10 months

  • Change in the Stroop Color-Word Test

    Change from baseline at 4 and 10 months

  • Change in the Trail Making Test

    Change from baseline at 4 and 10 months

  • Change in the Categorical and phonemic verbal fluency test

    Change from baseline at 4 and 10 months

  • Change in the Tower of London test

    Change from baseline at 4 and 10 months

  • +15 more secondary outcomes

Study Arms (2)

Remediation program via a "serious game"

EXPERIMENTAL

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

Diagnostic Test: Serious game

Classic care (French Haute Autorité de Santé)

PLACEBO COMPARATOR

Classic care (recommended by French Haute Autorité de Santé)

Diagnostic Test: Usual HAS care

Interventions

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.

Remediation program via a "serious game"
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.

Classic care (French Haute Autorité de Santé)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Arras

Arras, Hauts-de-France, 62000, France

RECRUITING

CH LENS

Lens, Hauts-de-France, 62300, France

RECRUITING

CHRU

Lille, Hauts-de-France, 59000, France

RECRUITING

Saint Vincent hospital

Lille, Hauts-de-France, 59000, France

RECRUITING

Saint-Philibert hospital

Lomme, Nord, 59462, France

RECRUITING

Charles Nicolle Hospital

Rouen, Normandy, 76000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38033375DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bruno Lenne

    Hôpital Saint-Vincent de Paul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lausiaux, MD, PhD

CONTACT

03.20.22.52.69lansiaux.amelie@ghicl.net

Elodie Moutailler

CONTACT

03.20.22.52.69moutailler.elodie@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a blinded study for neuropsychological assessment.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 1 Control group 1 Experimental group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 5, 2021

Study Start

October 8, 2021

Primary Completion

April 4, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)