Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis — TELECOG-MS  

Multiple Sclerosis Clinical Trial

Official title: Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Sclerosis

• NCT number: NCT05611047
• Study type: Interventional
• Source: University Hospital, Bordeaux
• Contact: Aurélie RUET, Prof
• Phone: 05 56 79 55 21
• Email: aurelie.ruet@chu-bordeaux.fr
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Completion date: February 2025