The MS-CEBA study: determining Cognitive, Energetic, Behavioural and Affective (CEBA) profiles in Multiple Sclerosis
- Conditions
- Multiple Sclersosis10007951
- Registration Number
- NL-OMON53263
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Criteria for inclusion: confirmed diagnosis of MS (subtypes: remitting MS
[RRMS], primary progressive MS [PPMS] and secondary progressive MS [SPMS]), age
18 to 70, being able to participate in a short neuropsychological assessment
(NPA) as judged by the MS clinician (neurologist, rehabilitation physician)
and/or investigator (neuropsychologist), with adequate control of the Dutch
language. In order to be eligible to participate in this study, the group of
HC*s must be matched to the patient group on age and education level. This will
be done by the investigator (experienced neuropsychologist).
Patients as well as HC*s whose physical and/or cognitive condition is impaired
in such a way that they are not able to complete the NPA cannot participate in
this study. In addition, patients and HC*s cannot participate when they suffer
from other self-reported neurological and/or major psychiatric conditions.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is CEBA profile, which is latent and thus needs to be<br /><br>derived from the neuropsychological tests and questionnaires regarding the CEBA<br /><br>domains. To decide whether a CEBA domain is impaired, raw scores on the<br /><br>neuropsychological tests and questionnaires regarding each CEBA domain will be<br /><br>converted into normed scores. These normed scores will be compared to a cut-off<br /><br>score, based on which will be decided whether the domain at hand is either<br /><br>impaired or not impaired. See 8. METHOD of the research protocol for the<br /><br>neuropsychological tests and questionnaires used in each of the CEBA domains. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are demographic information (derived from medical<br /><br>records), level of societal participation (derived from the score on the Impact<br /><br>on Participation and Autonomy (IPA) questionnaire), and subjective burden<br /><br>(obtained by conducting a short anamnesis). </p><br>