NCT03471338: SEPIA

Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme

Completed NA Last updated 25 July 2025

What this trial tests

NA trial testing Cognitive rehabilitation in Relapsing Remitting Multiple Sclerosis in 40 participants. Completed in 31 May 2024.

Timeline

31 October 2017

Primary endpoint
31 May 2023

31 May 2024

Quick facts

Lead sponsor	University Hospital, Caen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	other
Enrollment	40
Start date	31 October 2017
Primary completion	31 May 2023
Estimated completion	31 May 2024
Sites	1 location across France

Drugs / interventions tested

• Cognitive rehabilitation
• Standard Psychological care

Conditions studied

• Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →
• Secondary Progressive Multiple Sclerosis — all drugs for Secondary Progressive Multiple Sclerosis →

Sponsor

University Hospital, Caen

Who can join

Adults 18 to 65, any sex, with Relapsing Remitting Multiple Sclerosis or Secondary Progressive Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.

The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.

In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.

This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Memory rehabilitation for people with multiple sclerosis.
   Taylor LA, Mhizha-Murira JR, Smith L, Potter KJ, et al · · 2021 · cited 26× · PMID 34661282 · DOI 10.1002/14651858.cd008754.pub4
2. Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial.
   Harand C, Daniel F, Mondou A, Chevanne D, et al · · 2019 · cited 4× · PMID 31665039 · DOI 10.1186/s13063-019-3715-7