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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03471338

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.).

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis	Behavioral: Cognitive rehabilitation Behavioral: Standard Psychological care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 31, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Patients benefit cognitive rehabilitation	Behavioral: 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.
Sham Comparator: Standard Psychological care Patients do not benefit cognitive rehabilitation	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.

Arm

Intervention/Treatment

Experimental: Experimental Group

Patients benefit cognitive rehabilitation

Behavioral: 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.

Sham Comparator: Standard Psychological care

Patients do not benefit cognitive rehabilitation

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.

Outcome Measures

Primary Outcome Measures

Efficacy of cognitive rehabilitation on quality of life at short term. [10 weeks]
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on quality of life at long term. [34 weeks]
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.

Secondary Outcome Measures

Efficacy of cognitive rehabilitation on self-esteem at short term. [10 weeks]
Self-esteem will be assessed by measuring the change of the scores of the SEI (Self Esteem Inventory) scale between baseline and short-term. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on self-esteem long term. [34 weeks]
Self-esteem will be assessed by measuring the change of the scores of the SEI (Self Esteem Inventory) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on depression at short term. [10 weeks]
Depression will be assessed by measuring the change of the scores of MADRS (Montgomery and Asberg Depression Rating Scale) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on depression at long term. [34 weeks]
Depression will be assessed by measuring the change of the scores of MADRS (Montgomery and Asberg Depression Rating Scale) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on cognition at short term. [10 weeks]
Cognition will be assessed by measuring the change of the scores of the BICAMS (Brief International Assessment for Multiple Sclerosis) battery between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on cognition at long term. [34 weeks]
Cognition will be assessed by measuring the change of the scores of the BICAMS (Brief International Assessment for Multiple Sclerosis) battery between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on metacognition at short term. [10 weeks]
Metacognition will be assessed by measuring the change of the scores of the MCQ-30 (Metacognitions Questionnaire-30) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on metacognition at long term. [34 weeks]
Metacognition will be assessed by measuring the change of the scores of the MCQ-30 (Metacognitions Questionnaire-30) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on fatigue at short term [10 weeks]
Fatigue will be assessed by measuring the change of the scores of the EMIF-SEP (Echelle Modifiée d'Impact de la Fatigue dans la Sclérose En Plaques) scale between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on fatigue at long term [34 weeks]
Fatigue will be assessed by measuring the change of the scores of the EMIF-SEP (Echelle Modifiée d'Impact de la Fatigue dans la Sclérose En Plaques) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on sleep at short term [10 weeks]
Sleep will be assessed by measuring the change of the scores of the PSQI (Pittsburgh Sleep Quality Index) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on sleep at long term [34 weeks]
Sleep will be assessed by measuring the change of the scores of the PSQI (Pittsburgh Sleep Quality Index) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on anxiety at short term. [10 weeks]
Anxiety will be assessed by measuring the change of the scores of HAMA (HAMilton Anxiety) scale between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on anxiety at long term. [34 weeks]
Anxiety will be assessed by measuring the change of the scores of HAMA (HAMilton Anxiety) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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