We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme (SEPIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471338
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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 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.).


Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Behavioral: Cognitive rehabilitation Behavioral: Standard Psychological care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: Experimental Group
Patients benefit cognitive rehabilitation
Behavioral: Cognitive rehabilitation

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.


Sham Comparator: Standard Psychological care
Patients do not benefit cognitive rehabilitation
Behavioral: Standard Psychological care

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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Efficacy of cognitive rehabilitation on self-esteem at short term. [ Time Frame: 10 weeks ]
    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.

  2. Efficacy of cognitive rehabilitation on self-esteem long term. [ Time Frame: 34 weeks ]
    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.

  3. Efficacy of cognitive rehabilitation on depression at short term. [ Time Frame: 10 weeks ]
    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.

  4. Efficacy of cognitive rehabilitation on depression at long term. [ Time Frame: 34 weeks ]
    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.

  5. Efficacy of cognitive rehabilitation on cognition at short term. [ Time Frame: 10 weeks ]
    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.

  6. Efficacy of cognitive rehabilitation on cognition at long term. [ Time Frame: 34 weeks ]
    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.

  7. Efficacy of cognitive rehabilitation on metacognition at short term. [ Time Frame: 10 weeks ]
    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.

  8. Efficacy of cognitive rehabilitation on metacognition at long term. [ Time Frame: 34 weeks ]
    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.

  9. Efficacy of cognitive rehabilitation on fatigue at short term [ Time Frame: 10 weeks ]
    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.

  10. Efficacy of cognitive rehabilitation on fatigue at long term [ Time Frame: 34 weeks ]
    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.

  11. Efficacy of cognitive rehabilitation on sleep at short term [ Time Frame: 10 weeks ]
    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.

  12. Efficacy of cognitive rehabilitation on sleep at long term [ Time Frame: 34 weeks ]
    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.

  13. Efficacy of cognitive rehabilitation on anxiety at short term. [ Time Frame: 10 weeks ]
    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.

  14. Efficacy of cognitive rehabilitation on anxiety at long term. [ Time Frame: 34 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • - 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471338


Contacts
Layout table for location contacts
Contact: Gilles Defer, Pr 231064620 ext +33 defer-gi@chu-caen.fr

Locations
Layout table for location information
France
University Hospital of Caen Recruiting
Caen, Calvados, France, 14000
Contact: Gilles Defer, Pr         
Sponsors and Collaborators
University Hospital, Caen
Investigators
Layout table for investigator information
Principal Investigator: Gilles Defer, Pr Neurology Department, Caen University Hospital
Layout table for additonal information
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03471338    
Other Study ID Numbers: 2017-A01736-47
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: August 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
multiple sclerosis
cognition
neuropsychology
cognitive rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes