Multiple SclerosisTELECOG-MSNCT05611047
Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis
A study testing Clinical assessment, Classical cognitive evaluation of several domains: and Ecological evaluation in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Clinical assessment, Classical cognitive evaluation of several domains: and Ecological evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesFrance
- Study dates
- 21 Feb 2023to 19 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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 join
- 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
Show all 10Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux - Service de neurologie
Bordeaux
CHU de Clermont-Ferrand - Service de neurologie
Clermont-Ferrand
CHU de Dijon-Bourgogne - Service de neurologie
Dijon
CH de Dunkerque - Service de neurologie
Dunkirk
Hôpital Saint Vincent de Paul - Service de neurologie
Lille
CHU de Montpellier - Service de neurologie
Montpellier
CHI Hôpital de Poissy Saint Germain en Laye - Service de neurologie
Poissy
About this study
Official title: Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
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).
Read more
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
- Being tested
- Clinical assessment, Classical cognitive evaluation of several domains:, Ecological evaluation, Patent reported outcomes (PRO's), Telerehabilitation : active procedure
- Keywords
- Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, cognitive impairment, ecological assessment, telerehabilitation
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases of the Nervous System, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded
Classical cognitive evaluation of several domains:Other
Information processing speed (IPS) Working memory (WM) Executive functions (EF) Episodic memory (EM) Premorbid intelligence quotient (IQ) Multidomain or complex task
Ecological evaluationOther
Virtual reality task : Urban DailyCog©
Patent reported outcomes (PRO's)Behavioural
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 procedureOther
The Cognitive rehabilitation (CR) consists of weekly 45 minutes online individual session with the unblinded Speech Therapist.
Telerehabilitation : comparator procedureOther
Once per week over a 12-week period completed by daily online exercises performed by the patient 4 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Active cognitive rehabilitation | Experimental | Not described Receives: Other: Clinical assessment; Other: Classical cognitive evaluation of several domains:; Other: Ecological evaluation; Behavioral: Patent reported outcomes (PRO's); Other: Telerehabilitation : active procedure |
| Sham cognitive rehabilitation | Active comparator | Not described Receives: Other: Clinical assessment; Other: Classical cognitive evaluation of several domains:; Other: Ecological evaluation; Behavioral: Patent reported outcomes (PRO's); Other: Telerehabilitation : comparator procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of two of the four reaction time z scores over the 12 weeks of training in the ecological assessment of cognitive impairment (CI) using the Urban DailyCog®.
Measured: 12 weeks after baseline (Day 0)
Secondary outcomes (13)
Change in the neuropsychological tests raw scores between baseline (W0) and after rehabilitation (W12) between the two groups
Measured: 12 weeks after baseline (Day 0)
Change in the neuropsychological tests raw scores between visit W12 and visit W24 between the two groups.
Measured: 24 weeks after baseline (Day 0)
Change in information processing speed (IPS), composite z scores between W0-W12 and W12-W24
Measured: 24 weeks after baseline (Day 0)
Change in attention and working memory (WM) domain neuropsychological tests composite z scores and raw scores between W0-W12 and W12-W24 in subgroups of patients affected for these domains
Measured: 24 weeks after baseline (Day 0)
Change in the sum of the 4 reaction time differences over the 12 weeks of training in the ecological assessment of CI using the Urban DailyCog®.
Measured: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Measured: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (daily cognitive functioning) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Measured: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Measured: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Measured: 12 weeks after baseline (Day 0)
Change in the PROs (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Measured: 24 weeks after baseline (Day 0)
Change in the PROs (daily cognitive) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Measured: 24 weeks after baseline (Day 0)
Change in the PROs (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Measured: 24 weeks after baseline (Day 0)
Change in the PROs (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Measured: 24 weeks after baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start21 Feb 2023
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Why it stopped: withdrawal of Celgene
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Aurélie RUET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611047
- Sponsor's protocol ID
- CHUBX 2021/60
- Acronym
- TELECOG-MS
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
- ClinicalTrials.gov ID
- NCT05611047
- Acronym / sponsor ID
- TELECOG-MS / CHUBX 2021/60
- Conditions
- Multiple Sclerosis
- Keywords
- Autoimmune Diseases of the Nervous System, Demyelinating Autoimmune Diseases, Demyelinating Diseases, Immune System Diseases, Nervous System Diseases, Pathologic Processes, cognitive impairment, ecological assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: withdrawal of Celgene
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cognitive rehabilitation | Experimental | Other: Clinical assessment, Other: Classical cognitive evaluation of several domains:, Other: Ecological evaluation, Behavioral: Patent reported outcomes (PRO's), Other: Telerehabilitation : active procedure |
| Sham cognitive rehabilitation | Active comparator | Other: Clinical assessment, Other: Classical cognitive evaluation of several domains:, Other: Ecological evaluation, Behavioral: Patent reported outcomes (PRO's), Other: Telerehabilitation : comparator procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentMS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded | Other | Active cognitive rehabilitation, Sham cognitive rehabilitation |
| 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 | Active cognitive rehabilitation, Sham cognitive rehabilitation |
| Ecological evaluationVirtual reality task : Urban DailyCog© | Other | Active cognitive rehabilitation, Sham cognitive rehabilitation |
| 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) | Behavioural | Active cognitive rehabilitation, Sham cognitive rehabilitation |
| Telerehabilitation : active procedureThe Cognitive rehabilitation (CR) consists of weekly 45 minutes online individual session with the unblinded Speech Therapist. | Other | Active cognitive rehabilitation |
| Telerehabilitation : comparator procedureOnce per week over a 12-week period completed by daily online exercises performed by the patient 4 days a week. | Other | Sham cognitive rehabilitation |
Primary outcome
Improvement of two of the four reaction time z scores over the 12 weeks of training in the ecological assessment of cognitive impairment (CI) using the Urban DailyCog®.
Time frame: 12 weeks after baseline (Day 0)
13 secondary outcomes
Change in the neuropsychological tests raw scores between baseline (W0) and after rehabilitation (W12) between the two groups
Time frame: 12 weeks after baseline (Day 0)
Change in the neuropsychological tests raw scores between visit W12 and visit W24 between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in information processing speed (IPS), composite z scores between W0-W12 and W12-W24
Time frame: 24 weeks after baseline (Day 0)
Change in attention and working memory (WM) domain neuropsychological tests composite z scores and raw scores between W0-W12 and W12-W24 in subgroups of patients affected for these domains
Time frame: 24 weeks after baseline (Day 0)
Change in the sum of the 4 reaction time differences over the 12 weeks of training in the ecological assessment of CI using the Urban DailyCog®.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (daily cognitive functioning) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the patient-reported outcomes (PROs) (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between baseline (W0) and after rehabilitation (W12) between the two groups.
Time frame: 12 weeks after baseline (Day 0)
Change in the PROs (depression anxiety) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (daily cognitive) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (fatigue) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Change in the PROs (Health-Related Quality of Life) and Subjective cognitive deficits questionnaire (PDQ and DCAQ) between W0 and the 24-weeks follow-up (W24) between the two groups.
Time frame: 24 weeks after baseline (Day 0)
Results and safety
The study was stopped early (reason given: withdrawal of Celgene). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie RUET, Prof principal investigator
University Hospital, Bordeaux
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment, Classical cognitive evaluation of several domains: and Ecological evaluation in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: withdrawal of Celgene). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of two of the four reaction time z scores over the 12 weeks of training in the ecological assessment of cognitive impairment (CI) using the Urban DailyCog®. (time frame: 12 weeks after baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.