Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis

Last updated: February 6, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Memory Problems

Treatment

Ecological evaluation

Classical cognitive evaluation of several domains:

Telerehabilitation : active procedure

Clinical Study ID

NCT05611047
CHUBX 2021/60
  • Ages 18-55
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female;
  • Age 18-55 years;
  • Native French speaking;
  • Definite diagnosis of Relapsing-remitting MS (RRMS) according to McDonald 2017criteria;
  • Disease duration> 12 months and ≤ 15 years;
  • Computerized-Screening Cognitive Test (CSCT) score ≤ - 1.282 Standard Deviations (SD) (10th percentile) and/or cognitive complaint;
  • 3 scores -1 SDa or 2 scores -1.5 SDb at least 2 of 5 baseline preselectionneuropsychological battery tests in one of the following domains: processing speed orattention or working memory (SDMT, subtests alert, divided attention, visual scanningfor selective attention, TAP and subtest working memory of the WAIS IV) and SDMT scorenot ≤ -3 SD;
  • Able to use a computer with Windows operating system, an internet connection;
  • Being affiliated to health insurance
  • Having signed an informed consent (at the latest on the day of inclusion and beforeany examination required by research)

Exclusion

Exclusion Criteria:

  • Previous history of other neurological disease;
  • Psychiatric comorbidity including severe depression according to Diagnostic andStatistical Manual-IV (DSM-IV);
  • Current dependence on alcohol or other addiction to toxic;
  • Disabling visual or motor problems preventing participation to neuropsychologicalassessments;
  • Change of psychotropic drug or disease-modifying therapies since less than one month;
  • MS relapse in the month preceding the inclusion visit
  • Illiteracy, ie: unable to count or to read;
  • Acquisition disorders: dyslexia, dysphasia, dyscalculia and dyspraxia;
  • Pregnant or breastfeeding women;
  • Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their libertyby a judicial or administrative decision, minors, persons of legal age who are theobject of a legal protection measure or unable to express their consent).

Study Design

Total Participants: 150
Treatment Group(s): 6
Primary Treatment: Ecological evaluation
Phase:
Study Start date:
February 21, 2023
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • CHU de Bordeaux - Service de neurologie

    Bordeaux,
    France

    Active - Recruiting

  • CHU de Clermont-Ferrand - Service de neurologie

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU de Dijon-Bourgogne - Service de neurologie

    Dijon,
    France

    Site Not Available

  • CH de Dunkerque - Service de neurologie

    Dunkerque,
    France

    Site Not Available

  • Hôpital Saint Vincent de Paul - Service de neurologie

    Lille,
    France

    Site Not Available

  • CHU de Montpellier - Service de neurologie

    Montpellier,
    France

    Site Not Available

  • CHI Hôpital de Poissy Saint Germain en Laye - Service de neurologie

    Poissy,
    France

    Site Not Available

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