Clinical trial NCT06016309: The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis
Official title: The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Groningen
First posted: 2023-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Multiple Sclerosis (pwMS).

Brief summary: Multiple Sclerosis (MS) is an invalidating neurological disease known to cause physical symptoms, which usually are the main focus of treatment. However, non-physical, more neuropsychological, symptoms also frequently occur, concerning the Cognitive, Energetic, Behavioural and Affective (CEBA) domains. Symptoms in the CEBA domains are known to negatively affect societal participation, and thereby quality of life. Unfortunately, despite their negative consequences, CEBA symptoms are not always timely recognized in people with MS (pwMS). Moreover, despite the fact that there are various effective neuropsychological treatments available for neurological patients with these symptoms, most pwMS do not yet receive these treatments.

Although findings in group studies confirm that each of the CEBA domains can be affected in pwMS and correlations between symptoms regarding different CEBA domains have been found, there are large differences between individual pwMS with regard to which CEBA symptoms co-occur and which CEBA symptoms prevail. In order to optimize care for pwMS (e.g. timely referring patients to suiting neuropsychological treatment) there is need for a large scale study investigating over the whole range of CEBA symptoms how frequent these occur, whether and how symptoms co-occur, and thus if CEBA profiles can be identified. Identification of CEBA profiles can serve to quickly identify pwMS with neuropsychological problems in clinical practice, and provide an indication for possible neuropsychological treatment. If CEBA profiles are identified, it is considered likely that multiple CEBA symptoms will be prominent within a single CEBA profile. Here, subjective burden of pwMS can play an important role in determining which symptoms the main focus should be on in possible neuropsychological treatment.

Currently, a clear and standardized procedure with a feasible neuropsychological screening instrument quickly identifying and combining CEBA profile and subjective burden, providing a suitable indication for possible neuropsychological treatment, is lacking.

The aim of the present study is identifying CEBA profiles in pwMS and subsequently developing a feasible screening instrument allowing quick identification of CEBA profile and subjective burden of pwMS in clinical practice, providing a suitable indication for possible neuropsychological treatment. If needed, combining of or adjustments to existing neuropsychological treatments will be suggested in order meet the needs of pwMS with CEBA symptoms. All of this with the ultimate aim to improve societal participation, and accordingly quality of life, of pwMS.


Eligibility criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria:

Inclusion Criteria:

* Confirmed MS diagnosis (all subtypes);
* Age18-70;
* Adequate command of the Dutch language.

Exclusion Criteria:

* Not being able to participate in a short neuropsychological assessment (NPA) as judged by the MS clinician and/or investigator;
* Presence of any other neurological and/or major psychiatric condition.

The group of HC's will be matched to the patient group on age and education level.

Primary outcomes:
measure: Cognition
timeFrame: 6-48 months
measure: Energy
timeFrame: 6-48 months
measure: Behaviour
timeFrame: 6-48 months
measure: Affect
timeFrame: 6-48 months
Secondary outcomes:
measure: Level of societal participation
timeFrame: 6-48 months
measure: Subjective burden
timeFrame: 6-48 months
measure: Demographic information
timeFrame: 6-48 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
Study officials:
affiliation: Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
name: Joke Spikman, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: