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

NCT06016309 | Recruiting

• 1 other identifier: NL2023.202315914
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• Cognition

  The main study parameter is CEBA profile, which is latent and thus needs to be derived from the scores on neuropsychological tests and questionnaires regarding the CEBA domains, using latent profile analysis. Neuropsychological instruments regarding the Cognitive domain: * Neuropsychological tests for information processing speed (Symbol Digit Modalities Test \& Trail Making Test A) * Neuropsychological tests for attentive/executive control (Trail Making Test A + B \& Letterfluency) * Neuropsychological tests for memory (15 Word Test \& Digit Span Test of the Wechsler Adult Intelligence Scale)

  6-48 months

• Energy

  The main study parameter is CEBA profile, which is latent and thus needs to be derived from the scores on neuropsychological tests and questionnaires regarding the CEBA domains, using latent profile analysis. Neuropsychological instrument regarding the Energetic domain: \- Questionnaire for mental and physical fatigue (Dutch Multifactor Fatigue Scale)

  6-48 months

• Behaviour

  The main study parameter is CEBA profile, which is latent and thus needs to be derived from the scores on neuropsychological tests and questionnaires regarding the CEBA domains, using latent profile analysis. Neuropsychological instruments regarding the Behavioural domain: * Neuropsychological test for social cognition (Facial Expressions of Emotion - Stimuli and Tests) * Subscales of a questionnaire for social cognitive symptoms (Dysexecutive Questionnaire - self and proxy)

  6-48 months

• Affect

  The main study parameter is CEBA profile, which is latent and thus needs to be derived from the scores on neuropsychological tests and questionnaires regarding the CEBA domains, using latent profile analysis. Neuropsychological instrument regarding the Affective domain: \- Questionnaire for anxiety and depression (Hospital Anxiety and Depression Scale)

  6-48 months

Secondary Outcomes (3)

• Level of societal participation

  6-48 months

• Subjective burden

  6-48 months

• Demographic information

  6-48 months

Study Arms (2)

Phase 1

In Phase 1 of the study, we aim to include a minimum of 300 patients to identify how often which CEBA symptoms occur among pwMS and which symptoms cluster together, forming CEBA profiles. In addition, in Phase 1, an on age and education level matched group of 100 Healthy controls will be included to allow comparison of performance-based measures. In Phase 2 of the study, we aim to include a minimum of 100 patients, after approximately two years, to investigate whether we can replicate the results of Phase 1, validating the different CEBA profiles.

Other: There is no intervention.

Retest Phase 1

After a year, a retest of around 50 patients will take place in order to determine whether CEBA symptoms are stable over time which is important information in deciding whether CEBA profiles can be used as a guide for further care.

Other: There is no intervention.

Interventions

There is no intervention. OTHER

There is no intervention.

Phase 1; Retest Phase 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Multiple Sclerosis (pwMS).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator

Study Sites (1)

University Medical Center Groningen (UMCG)

Groningen, Provincie Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (1)

• Reinhardt A, Rakers SE, Heersema DJ, Beenakker EAC, Meilof JF, Timmerman ME, Spikman JM. Protocol for the MS-CEBA study: an observational, prospective cohort study identifying Cognitive, Energetic, Behavioural and Affective (CEBA) profiles in Multiple Sclerosis to guide neuropsychological treatment choice. BMC Neurol. 2024 Jun 28;24(1):224. doi: 10.1186/s12883-024-03737-6.

  PMID: 38943063 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joke Spikman, Prof. Dr.

  Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anniek Reinhardt, MSc./Drs.

CONTACT

+3150 3619431; a.reinhardt@umcg.nl

Sandra Rakers, Dr.

CONTACT

+3150 3612409; s.e.rakers@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 29, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2024-12

Locations

NL (1)