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NCT06016309Recruiting

The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
25 Jul 2023
Start date
20 Jul 2023
Primary completion date
20 Jul 2027
Lead sponsor
University Medical Center Groningen
NCT number
NCT06016309

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 20 Jul 2023 to the primary completion date, 20 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • 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.

Other

  • Not being able to participate in a short neuropsychological assessment (NPA) as judged by the MS clinician and/or investigator;

Who the study is looking for

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

Criteria the registry did not label

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

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Medical Center Groningen (UMCG)
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.