Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis

NCT ID: NCT05611047

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2025-02-19

Brief 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active cognitive rehabilitation

Group Type: EXPERIMENTAL

Clinical assessment

Intervention Type: OTHER

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

Classical cognitive evaluation of several domains:

Intervention Type: OTHER

Information processing speed (IPS) Working memory (WM) Executive functions (EF) Episodic memory (EM) Premorbid intelligence quotient (IQ) Multidomain or complex task

Ecological evaluation

Intervention Type: OTHER

Virtual reality task : Urban DailyCog©

Patent reported outcomes (PRO's)

Intervention Type: BEHAVIORAL

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)

Telerehabilitation : active procedure

Intervention Type: OTHER

The Cognitive rehabilitation (CR) consists of weekly 45 minutes online individual session with the unblinded Speech Therapist.

Sham cognitive rehabilitation

Group Type: ACTIVE_COMPARATOR

Clinical assessment

Intervention Type: OTHER

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

Classical cognitive evaluation of several domains:

Intervention Type: OTHER

Information processing speed (IPS) Working memory (WM) Executive functions (EF) Episodic memory (EM) Premorbid intelligence quotient (IQ) Multidomain or complex task

Ecological evaluation

Intervention Type: OTHER

Virtual reality task : Urban DailyCog©

Patent reported outcomes (PRO's)

Intervention Type: BEHAVIORAL

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)

Telerehabilitation : comparator procedure

Intervention Type: OTHER

Once per week over a 12-week period completed by daily online exercises performed by the patient 4 days a week.

Interventions

Clinical assessment

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

Intervention Type: OTHER

Classical cognitive evaluation of several domains:

Information processing speed (IPS) Working memory (WM) Executive functions (EF) Episodic memory (EM) Premorbid intelligence quotient (IQ) Multidomain or complex task

Intervention Type: OTHER

Ecological evaluation

Virtual reality task : Urban DailyCog©

Intervention Type: OTHER

Patent reported outcomes (PRO's)

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)

Intervention Type: BEHAVIORAL

Telerehabilitation : active procedure

The Cognitive rehabilitation (CR) consists of weekly 45 minutes online individual session with the unblinded Speech Therapist.

Intervention Type: OTHER

Telerehabilitation : comparator procedure

Once per week over a 12-week period completed by daily online exercises performed by the patient 4 days a week.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie RUET, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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

Countries

France

Other Identifiers

CHUBX 2021/60

Identifier Type: -

Identifier Source: org_study_id