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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05611047
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Bordeaux
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Aurélie RUET, Prof
Principal Investigator Affiliation CHU Bordeaux
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Active cognitive rehabilitation

Active Comparator: Sham cognitive rehabilitation

Interventions

Other: - Clinical assessment

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

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

Other: - Ecological evaluation

Virtual reality task : Urban DailyCog©

Behavioral: - 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)

Other: - Telerehabilitation : active procedure

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Bordeaux - Service de neurologie, Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux - Service de neurologie

Bordeaux, ,

Site Contact

Aurélie RUET, Prof

[email protected]

05 56 79 55 21 #+33

Clermont-Ferrand, France

Status

Not yet recruiting

Address

CHU de Clermont-Ferrand - Service de neurologie

Clermont-Ferrand, ,

Site Contact

Pierre CLAVELOU, Prof

[email protected]

05 56 79 55 21

Dijon, France

Status

Not yet recruiting

Address

CHU de Dijon-Bourgogne - Service de neurologie

Dijon, ,

Site Contact

Thibault MOREAU, Prof

[email protected]

05 56 79 55 21

CH de Dunkerque - Service de neurologie, Dunkerque, France

Status

Not yet recruiting

Address

CH de Dunkerque - Service de neurologie

Dunkerque, ,

Site Contact

Jean-Bertin NKENDJUO, MD

[email protected]

05 56 79 55 21

Lille, France

Status

Not yet recruiting

Address

Hôpital Saint Vincent de Paul - Service de neurologie

Lille, ,

Site Contact

Arnaud KWIATKOWSKI, MD

[email protected]

05 56 79 55 21

Montpellier, France

Status

Not yet recruiting

Address

CHU de Montpellier - Service de neurologie

Montpellier, ,

Site Contact

Xavier AYRIGNAC, MD

[email protected]

05 56 79 55 21

Poissy, France

Status

Not yet recruiting

Address

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

Poissy, ,

Site Contact

Olivier HEINZLEF, MD

[email protected]

05 56 79 55 21

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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