Multiple SclerosisMS-CEBANCT06016309
The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jul 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with Multiple Sclerosis (pwMS).
Who may be able to join
- Confirmed MS diagnosis (all subtypes);
- Age18-70;
- Adequate command of the Dutch language.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen (UMCG)
Groningen, Provincie Groningen, 9700 RB
Anniek Reinhardt, MSc./Drs., +3150 3619431, a.reinhardt@umcg.nl
About this study
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.
Read more
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
- Being tested
- There is no intervention.
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6-48 months
Secondary outcomes (3)
Level of societal participation
Level of societal participation will be derived from the score on a questionnaire called 'Impact on Participation and Autonomy (IPA)'
Measured: 6-48 months
Subjective burden
Subjective burden will be obtained through conducting an anamnesis.
Measured: 6-48 months
Demographic information
Demographic information will be derived from medical records and anamnesis.
Measured: 6-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start20 Jul 2023
- Primary completion20 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Sponsor
- Investigators
- Joke Spikman, Prof. Dr., Principal investigator, Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016309
- Sponsor's protocol ID
- NL2023.202315914
- Acronym
- MS-CEBA
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38943063
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06016309
- Acronym / sponsor ID
- MS-CEBA / NL2023.202315914
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: There is no intervention.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. |
| Retest Phase 1 | – | Other: There is no intervention.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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with Multiple Sclerosis (pwMS).
Key inclusion criteria (3 listed)
- Confirmed MS diagnosis (all subtypes);
- Age18-70;
- Adequate command of the Dutch language.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention.There is no intervention. | Other | Phase 1, Retest Phase 1 |
Primary outcome
Cognition
Time frame: 6-48 months
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)
Energy
Time frame: 6-48 months
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)
Behaviour
Time frame: 6-48 months
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)
Affect
Time frame: 6-48 months
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)
3 secondary outcomes
Level of societal participation
Time frame: 6-48 months
Subjective burden
Time frame: 6-48 months
Demographic information
Time frame: 6-48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 38943063Reinhardt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joke Spikman, Prof. Dr. principal investigator
Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anniek Reinhardt, MSc./Drs. (+3150 3619431, a.reinhardt@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: 6-48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.