Relapsing Remitting Multiple SclerosisSEPIANCT03471338
Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
A study testing Cognitive rehabilitation and Standard Psychological care in people with Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
Trial summary
Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- What is being tested?
- Cognitive rehabilitation and Standard Psychological care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2017to 31 May 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MS defined according to the McDonald criteria revised in 2010
- Men and women aged between 18 and 65 years
- RR and SP forms
- Duration of progression ≤ 25 years
- EDSS ≤ 5.5
- Lack of disease activity as defined by the new Lublin criteria (2013)
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- Cognitive complaint and/or cognitive disorders according to the investigator's judgement
- Impaired cognitive performance at least 1.65 SD below normative data at one test of the BCcogSEP battery
- French native language
- Owner of a laptop computer with Internet access
- Signing of the informed consent
Who cannot join
- - Other neurological, psychiatric or developmental diseases prior to the MS diagnosis
- Cranial trauma sequelae
- Chronic alcohol and/or drug consumption
- EDSS > 6
- Relapse and/or treatment with corticosteroids within the past month
- Persons deprived of liberty, minors, adults under wardship
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- Cognitive examination within the past 6 months (including in particular all or some of the tests proposed by this project)
- Presence of dementia according to DSM V criteria, or of cognitive disorders preventing the patient from undergoing cognitive tests or performing cognitive rehabilitation exercises
- Any visual or motor deficit preventing the patient from undergoing cognitive tests or performing cognitive rehabilitation exercises
Trial locations and contacts
1 site in 1 country.
About this study
Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.
The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.
Read more
In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.
This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).
- Being tested
- Cognitive rehabilitation, Standard Psychological care
- Keywords
- multiple sclerosis, cognition, neuropsychology, cognitive rehabilitation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitationBehavioural
At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.
At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.
At-home neuropsychological management (9 weeks): The patient performs the program (PRESCO software) on his computer autonomously at home at a rate of 3 sessions per week. A neuropsychologist performs at-home visits and weekly phone meetings to train the patient to the software, to encourage him to do exercises and to answer any software use-related questions.
At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.
Standard Psychological careBehavioural
At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.
At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.
At-home neuropsychological management (9 weeks): A neuropsychologist performs at-home visits and weekly phone meetings consisting in discussion of the patient's cognitive disorders.
At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients benefit cognitive rehabilitation Receives: Behavioral: Cognitive rehabilitation |
| Standard Psychological care | Sham comparator | Patients do not benefit cognitive rehabilitation Receives: Behavioral: Standard Psychological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of cognitive rehabilitation on quality of life at short term.
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on quality of life at long term.
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Secondary outcomes (14)
Efficacy of cognitive rehabilitation on self-esteem at short term.
Self-esteem will be assessed by measuring the change of the scores of the SEI (Self Esteem Inventory) scale between baseline and short-term. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on self-esteem long term.
Self-esteem will be assessed by measuring the change of the scores of the SEI (Self Esteem Inventory) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on depression at short term.
Depression will be assessed by measuring the change of the scores of MADRS (Montgomery and Asberg Depression Rating Scale) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on depression at long term.
Depression will be assessed by measuring the change of the scores of MADRS (Montgomery and Asberg Depression Rating Scale) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on cognition at short term.
Cognition will be assessed by measuring the change of the scores of the BICAMS (Brief International Assessment for Multiple Sclerosis) battery between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on cognition at long term.
Cognition will be assessed by measuring the change of the scores of the BICAMS (Brief International Assessment for Multiple Sclerosis) battery between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on metacognition at short term.
Metacognition will be assessed by measuring the change of the scores of the MCQ-30 (Metacognitions Questionnaire-30) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on metacognition at long term.
Metacognition will be assessed by measuring the change of the scores of the MCQ-30 (Metacognitions Questionnaire-30) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on fatigue at short term
Fatigue will be assessed by measuring the change of the scores of the EMIF-SEP (Echelle Modifiée d'Impact de la Fatigue dans la Sclérose En Plaques) scale between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on fatigue at long term
Fatigue will be assessed by measuring the change of the scores of the EMIF-SEP (Echelle Modifiée d'Impact de la Fatigue dans la Sclérose En Plaques) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on sleep at short term
Sleep will be assessed by measuring the change of the scores of the PSQI (Pittsburgh Sleep Quality Index) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on sleep at long term
Sleep will be assessed by measuring the change of the scores of the PSQI (Pittsburgh Sleep Quality Index) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Efficacy of cognitive rehabilitation on anxiety at short term.
Anxiety will be assessed by measuring the change of the scores of HAMA (HAMilton Anxiety) scale between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 10 weeks
Efficacy of cognitive rehabilitation on anxiety at long term.
Anxiety will be assessed by measuring the change of the scores of HAMA (HAMilton Anxiety) scale between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start31 Oct 2017
- Primary completion31 May 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Defer, Pr, Principal investigator, Neurology Department, Caen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471338
- Sponsor's protocol ID
- 2017-A01736-47
- Acronym
- SEPIA
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2018
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
- ClinicalTrials.gov ID
- NCT03471338
- Acronym / sponsor ID
- SEPIA / 2017-A01736-47
- Keywords
- multiple sclerosis, cognition, neuropsychology, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 20 Mar 2018 (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.
Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.
The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.
In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.
This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Cognitive rehabilitationPatients benefit cognitive rehabilitation |
| Standard Psychological care | Sham comparator | Behavioral: Standard Psychological carePatients do not benefit cognitive rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- MS defined according to the McDonald criteria revised in 2010
- Men and women aged between 18 and 65 years
- RR and SP forms
- Duration of progression ≤ 25 years
- EDSS ≤ 5.5
Key exclusion criteria (9 listed)
- - Other neurological, psychiatric or developmental diseases prior to the MS diagnosis
- Cranial trauma sequelae
- Chronic alcohol and/or drug consumption
- EDSS > 6
- Relapse and/or treatment with corticosteroids within the past 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 |
|---|---|---|
| Cognitive rehabilitationAt-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist. At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist. At-home neuropsychological management (9 weeks): The patient performs the program (PRESCO software) on his computer autonomously at home at a rate of 3 sessions per week. A neuropsychologist performs at-home visits and weekly phone meetings to train the patient to the software, to encourage him to do exercises and to answer any software use-related questions. At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit. | Behavioural | Experimental Group |
| Standard Psychological careAt-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist. At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist. At-home neuropsychological management (9 weeks): A neuropsychologist performs at-home visits and weekly phone meetings consisting in discussion of the patient's cognitive disorders. At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit. | Behavioural | Standard Psychological care |
Primary outcome
Efficacy of cognitive rehabilitation on quality of life at short term.
Time frame: 10 weeks
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and short-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
Efficacy of cognitive rehabilitation on quality of life at long term.
Time frame: 34 weeks
Quality of life will be assessed by measuring the change of the scores of MUSIQOL (MUltiple Sclerosis International Quality Of Life) questionnaire between baseline and long-term visits. Efficacy will be assessed by comparing theses scores between groups A and B.
14 secondary outcomes
Efficacy of cognitive rehabilitation on self-esteem at short term.
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on self-esteem long term.
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on depression at short term.
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on depression at long term.
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on cognition at short term.
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on cognition at long term.
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on metacognition at short term.
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on metacognition at long term.
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on fatigue at short term
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on fatigue at long term
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on sleep at short term
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on sleep at long term
Time frame: 34 weeks
Efficacy of cognitive rehabilitation on anxiety at short term.
Time frame: 10 weeks
Efficacy of cognitive rehabilitation on anxiety at long term.
Time frame: 34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
Gilles Defer, Pr principal investigator
Neurology Department, Caen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation and Standard Psychological care in people with Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by University Hospital, Caen at 1 site 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 25 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 1 site 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of cognitive rehabilitation on quality of life at short term. (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 25 Jul 2025.