Clinical trial NCT03471338: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
Official title: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Keywords: multiple sclerosis
cognition
neuropsychology
cognitive rehabilitation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.).


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

Primary outcomes:
measure: Efficacy of cognitive rehabilitation on quality of life at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on quality of life at long term.
timeFrame: 34 weeks
Secondary outcomes:
measure: Efficacy of cognitive rehabilitation on self-esteem at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on self-esteem long term.
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on depression at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on depression at long term.
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on cognition at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on cognition at long term.
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on metacognition at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on metacognition at long term.
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on fatigue at short term
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on fatigue at long term
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on sleep at short term
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on sleep at long term
timeFrame: 34 weeks
measure: Efficacy of cognitive rehabilitation on anxiety at short term.
timeFrame: 10 weeks
measure: Efficacy of cognitive rehabilitation on anxiety at long term.
timeFrame: 34 weeks
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
state: Calvados
Study officials:
affiliation: Neurology Department, Caen University Hospital
name: Gilles Defer, Pr
role: PRINCIPAL_INVESTIGATOR
References: