Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis (TELECOG-MS)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Telerehabilitation : active procedure; Behavioral: Patent reported outcomes (PRO's); Other: Ecological evaluation; Other: Clinical assessment; Other: Telerehabilitation : comparator procedure; Other: Classical cognitive evaluation of several domains:

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05611047

CHUBX 2021/60

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female;
• Age 18-55 years;
• Native French speaking;
• Definite diagnosis of Relapsing-remitting MS (RRMS) according to McDonald 2017 criteria;
• 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 preselection neuropsychological battery tests in one of the following domains: processing speed or attention or working memory (SDMT, subtests alert, divided attention, visual scanning for selective attention, TAP and subtest working memory of the WAIS IV) and SDMT score not ≤ -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 before any examination required by research)

Exclusion criteria

• Previous history of other neurological disease;
• Psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV);
• Current dependence on alcohol or other addiction to toxic;
• Disabling visual or motor problems preventing participation to neuropsychological assessments;
• 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 liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Active cognitive rehabilitation

Experimental group

Treatment:

Other: Telerehabilitation : active procedure

Behavioral: Patent reported outcomes (PRO's)

Other: Ecological evaluation

Other: Classical cognitive evaluation of several domains:

Other: Clinical assessment

Sham cognitive rehabilitation

Active Comparator group

Treatment:

Behavioral: Patent reported outcomes (PRO's)

Other: Ecological evaluation

Other: Classical cognitive evaluation of several domains:

Other: Telerehabilitation : comparator procedure

Other: Clinical assessment