Cognitive improvement program using a serious game for multiple sclerosis patients
e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial
This study tests a fun game designed to help people with multiple sclerosis improve their thinking skills and memory while they continue their regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 6 sites (Arras, Hauts-de-France and 5 other locations) |
| Trial ID | NCT04694534 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a cognitive remediation program that utilizes a serious game to enhance information processing speed and episodic memory learning in patients with multiple sclerosis. Cognitive impairments are common in these patients, affecting their daily lives and quality of life. The program aims to provide a novel approach to address these cognitive deficits, which are often overlooked in traditional treatment plans. Participants will engage in the serious game alongside their usual care to assess improvements in cognitive function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with relapsing-remitting or progressive multiple sclerosis who exhibit cognitive complaints.
Not a fit: Patients with severe cognitive deficits or those unable to engage with the software due to motor or sensory difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance cognitive functions and improve the quality of life for multiple sclerosis patients.
How similar studies have performed: While cognitive remediation strategies for multiple sclerosis are less studied, some existing research indicates that serious games may offer promising results in improving cognitive functions.
Eligibility criteria
Show full 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
Where this trial is running
Arras, Hauts-de-France and 5 other locations
- CH Arras — Arras, Hauts-de-France, France (Recruiting)
- Ch Lens — Lens, Hauts-de-France, France (Recruiting)
- Chru — Lille, Hauts-de-France, France (Recruiting)
- Saint Vincent hospital — Lille, Hauts-de-France, France (Recruiting)
- Saint-Philibert hospital — Lomme, Nord, France (Recruiting)
- Charles Nicolle Hospital — Rouen, Normandy, France (Recruiting)
Study contacts
- Principal investigator: Bruno Lenne — Hôpital Saint-Vincent de Paul
- Study coordinator: Amélie Lausiaux, MD, PhD
- Email: lansiaux.amelie@ghicl.net
- Phone: 03.20.22.52.69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.