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

NCT ID: NCT03471338

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2024-05-31

Brief Summary

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.).

Conditions

Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Group

Patients benefit cognitive rehabilitation

Group Type: EXPERIMENTAL

Cognitive rehabilitation

Intervention Type: BEHAVIORAL

At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.

At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.

At-home neuropsychological management (9 weeks): The patient performs the program (PRESCO software) on his computer autonomously at home at a rate of 3 sessions per week. A neuropsychologist performs at-home visits and weekly phone meetings to train the patient to the software, to encourage him to do exercises and to answer any software use-related questions.

At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.

Standard Psychological care

Patients do not benefit cognitive rehabilitation

Group Type: SHAM_COMPARATOR

Standard Psychological care

Intervention Type: BEHAVIORAL

At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.

At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.

At-home neuropsychological management (9 weeks): A neuropsychologist performs at-home visits and weekly phone meetings consisting in discussion of the patient's cognitive disorders.

At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.

Interventions

Cognitive rehabilitation

At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.

At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.

At-home neuropsychological management (9 weeks): The patient performs the program (PRESCO software) on his computer autonomously at home at a rate of 3 sessions per week. A neuropsychologist performs at-home visits and weekly phone meetings to train the patient to the software, to encourage him to do exercises and to answer any software use-related questions.

At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.

Intervention Type: BEHAVIORAL

Standard Psychological care

At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.

At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.

At-home neuropsychological management (9 weeks): A neuropsychologist performs at-home visits and weekly phone meetings consisting in discussion of the patient's cognitive disorders.

At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• MS defined according to the McDonald criteria revised in 2010
• Men and women aged between 18 and 65 years
• RR and SP forms
• Duration of progression ≤ 25 years
• EDSS ≤ 5.5
• Lack of disease activity as defined by the new Lublin criteria (2013)
• Cognitive complaint and/or cognitive disorders according to the investigator's judgement
• Impaired cognitive performance at least 1.65 SD below normative data at one test of the BCcogSEP battery
• French native language
• Owner of a laptop computer with Internet access
• Signing of the informed consent

Exclusion Criteria

• - Other neurological, psychiatric or developmental diseases prior to the MS diagnosis
• Cranial trauma sequelae
• Chronic alcohol and/or drug consumption
• EDSS > 6
• Relapse and/or treatment with corticosteroids within the past month
• Persons deprived of liberty, minors, adults under wardship
• Cognitive examination within the past 6 months (including in particular all or some of the tests proposed by this project)
• Presence of dementia according to DSM V criteria, or of cognitive disorders preventing the patient from undergoing cognitive tests or performing cognitive rehabilitation exercises
• Any visual or motor deficit preventing the patient from undergoing cognitive tests or performing cognitive rehabilitation exercises

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Defer, Pr

Role: PRINCIPAL_INVESTIGATOR

Neurology Department, Caen University Hospital

Locations

University Hospital of Caen

Caen, Calvados, France

Countries

France

Other Identifiers

2017-A01736-47

Identifier Type: -

Identifier Source: org_study_id