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

NCT06016309 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

Interventions

OTHER

There is no intervention.

There is no intervention.

Sponsors & Collaborators

  • University of Groningen

    collaborator OTHER
  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Joke Spikman, Prof. Dr. · Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2027-07-20
Completion
2027-12-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016309 on ClinicalTrials.gov