Treating cognitive impairment (CI) in multiple sclerosis (MS), the leading cause of disability due to nontraumatic neurological disease in young adults, is an important challenge. The contribution of CI to disability in MS has been increasingly recognized, and CI has been shown to decrease health-related quality of life (HR-QOL), even in the early stages of the disease. CI negatively impacts daily activities such as driving, vocational status, absenteeism, and instrumental activities in persons living with MS (PwMS). No medication has proven to have a consistent symptomatic effect on CI in MS, and disease-modifying therapies only have a small impact on CI progression. CI in MS is dominated by a slowdown in information processing speed (IPS), as well as by disturbances of more specific cognitive functions such as attention, episodic memory (EM), working memory (WM) and executive function (EF). The alteration of IPS has consequences for WM, attention, EF and EM. IPS impairment predicts subsequent disability and vocational status and changes in quality of life (QOL). Cognitive rehabilitation (CR) is the most promising approach for treating MS-related CI, as concluded by recent reviews and meta-analyses, despite important methodological shortcomings. Methodological limitations in early studies have led to disappointing results, and well-designed studies are still scarce. As noted recently, many studies lack a randomized controlled design that includes passive or active control conditions, primary neuropsychological end-points identified a priori, evidence of the sustainability of CR and the inclusion of near and far transfer outcomes. Tertiary outcomes of QOL, metacognition, or other patient-reported outcomes (PROs) are rarely used. In view of the results of these different studies, the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI, based on Rehacom software, using appropriates modules according to specific CI, but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patient's deficit, a more efficient supervision and meta-cognitive work. This program will be evaluated in terms of effectiveness on neuropsychological tests, effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline, an ecological evaluation and the impact on daily cognitive functioning. Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity. Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded
Information processing speed (IPS) Working memory (WM) Executive functions (EF) Episodic memory (EM) Premorbid intelligence quotient (IQ) Multidomain or complex task
Virtual reality task : Urban DailyCog©
Patent reported outcomes (PRO's) : Beck Depression Inventory (BDI), European Quality of Life-5 Dimensions (EQ-5D-5L) for Health-Related Quality of Life (HRQOL), Multiple Sclerosis Impact Scale-29 Items (MSIS-29), French version of the Modified Fatigue Impact Scale (EMISEP) and State trait anxiety inventory (STAI). Subjective cognitive deficits: Perceived Deficits Questionnaire (PDQ) and Cognitive Activities Questionnaire (DCAQ)
The Cognitive rehabilitation (CR) consists of weekly 45 minutes online individual session with the unblinded Speech Therapist.
Once per week over a 12-week period completed by daily online exercises performed by the patient 4 days a week.
CHU de Bordeaux - Service de neurologie
Bordeaux, France
CHU de Clermont-Ferrand - Service de neurologie
Clermont-Ferrand, France
CHU de Dijon-Bourgogne - Service de neurologie
Dijon, France
CH de Dunkerque - Service de neurologie
Dunkirk, France
Hôpital Saint Vincent de Paul - Service de neurologie
Lille, France
CHU de Montpellier - Service de neurologie
Montpellier, France
CHI Hôpital de Poissy Saint Germain en Laye - Service de neurologie
Poissy, France
Improvement of two of the four reaction time z scores over the 12 weeks of training in the ecological assessment of cognitive impairment (CI) using the Urban DailyCog®.
Time frame: 12 weeks after baseline (Day 0)
Change in the neuropsychological tests raw scores between baseline (W0) and after rehabilitation (W12) between the two groups
Time frame: 12 weeks after baseline (Day 0)
Change in the neuropsychological tests raw scores between visit W12 and visit W24 between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in information processing speed (IPS), composite z scores between W0-W12 and W12-W24
Time frame: 24 weeks after baseline (Day 0)
Change in attention and working memory (WM) domain neuropsychological tests composite z scores and raw scores between W0-W12 and W12-W24 in subgroups of patients affected for these domains
Time frame: 24 weeks after baseline (Day 0)
Change in the sum of the 4 reaction time differences over the 12 weeks of training in the ecological assessment of CI using the Urban DailyCog®.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (daily cognitive functioning) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the PROs (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (daily cognitive) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
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