Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- France7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 20 people enrolled
- Started
- 21 Feb 2023
- Ended
- 19 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Clinical assessment
- Classical cognitive evaluation of several domains:
- Ecological evaluation
- Patent reported outcomes (PRO's)
- Telerehabilitation : active procedure
- Telerehabilitation : comparator procedure
- Record updated
- 1 July 2025
- Why it stopped
- withdrawal of Celgene
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- Previous history of other neurological disease
- Psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV)
- Change of psychotropic drug or disease-modifying therapies since less than one month
- Acquisition disorders: dyslexia, dysphasia, dyscalculia and dyspraxia
- Illiteracy, ie: unable to count or to read
- 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)
- Current dependence on alcohol or other addiction to toxic
- Disabling visual or motor problems preventing participation to neuropsychological assessments
- MS relapse in the month preceding the inclusion visit
- Pregnant or breastfeeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Active cognitive rehabilitationTreatment being tested
Treatment: Clinical assessment, Classical cognitive evaluation of several domains:, Ecological evaluation, Patent reported outcomes (PRO's), and Telerehabilitation : active procedure
- Sham cognitive rehabilitationExisting treatment, for comparison
Treatment: Clinical assessment, Classical cognitive evaluation of several domains:, Ecological evaluation, Patent reported outcomes (PRO's), and Telerehabilitation : comparator procedure
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
- Record updated
- 1 July 2025