xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016309</url>
    </required_header>
    <id_info>
      <org_study_id>NL2023.202315914</org_study_id>
      <nct_id>NCT06016309</nct_id>
    </id_info>
    <brief_title>The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis</brief_title>
    <acronym>MS-CEBA</acronym>
    <official_title>The MS-CEBA Study: Determining Cognitive, Energetic, Behavioural and Affective (CEBA) Profiles in Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Groningen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Medical Center Groningen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Multiple Sclerosis (MS) is an invalidating neurological disease known to cause physical&#xD;
        symptoms, which usually are the main focus of treatment. However, non-physical, more&#xD;
        neuropsychological, symptoms also frequently occur, concerning the Cognitive, Energetic,&#xD;
        Behavioural and Affective (CEBA) domains. Symptoms in the CEBA domains are known to&#xD;
        negatively affect societal participation, and thereby quality of life. Unfortunately, despite&#xD;
        their negative consequences, CEBA symptoms are not always timely recognized in people with MS&#xD;
        (pwMS). Moreover, despite the fact that there are various effective neuropsychological&#xD;
        treatments available for neurological patients with these symptoms, most pwMS do not yet&#xD;
        receive these treatments.&#xD;
  &#xD;
        Although findings in group studies confirm that each of the CEBA domains can be affected in&#xD;
        pwMS and correlations between symptoms regarding different CEBA domains have been found,&#xD;
        there are large differences between individual pwMS with regard to which CEBA symptoms&#xD;
        co-occur and which CEBA symptoms prevail. In order to optimize care for pwMS (e.g. timely&#xD;
        referring patients to suiting neuropsychological treatment) there is need for a large scale&#xD;
        study investigating over the whole range of CEBA symptoms how frequent these occur, whether&#xD;
        and how symptoms co-occur, and thus if CEBA profiles can be identified. Identification of&#xD;
        CEBA profiles can serve to quickly identify pwMS with neuropsychological problems in clinical&#xD;
        practice, and provide an indication for possible neuropsychological treatment. If CEBA&#xD;
        profiles are identified, it is considered likely that multiple CEBA symptoms will be&#xD;
        prominent within a single CEBA profile. Here, subjective burden of pwMS can play an important&#xD;
        role in determining which symptoms the main focus should be on in possible neuropsychological&#xD;
        treatment.&#xD;
  &#xD;
        Currently, a clear and standardized procedure with a feasible neuropsychological screening&#xD;
        instrument quickly identifying and combining CEBA profile and subjective burden, providing a&#xD;
        suitable indication for possible neuropsychological treatment, is lacking.&#xD;
  &#xD;
        The aim of the present study is identifying CEBA profiles in pwMS and subsequently developing&#xD;
        a feasible screening instrument allowing quick identification of CEBA profile and subjective&#xD;
        burden of pwMS in clinical practice, providing a suitable indication for possible&#xD;
        neuropsychological treatment. If needed, combining of or adjustments to existing&#xD;
        neuropsychological treatments will be suggested in order meet the needs of pwMS with CEBA&#xD;
        symptoms. All of this with the ultimate aim to improve societal participation, and&#xD;
        accordingly quality of life, of pwMS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 20, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>6-48 months</time_frame>
      <description>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.&#xD;
  Neuropsychological instruments regarding the Cognitive domain:&#xD;
  Neuropsychological tests for information processing speed (Symbol Digit Modalities Test &amp; Trail Making Test A)&#xD;
  Neuropsychological tests for attentive/executive control (Trail Making Test A + B &amp; Letterfluency)&#xD;
  Neuropsychological tests for memory (15 Word Test &amp; Digit Span Test of the Wechsler Adult Intelligence Scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Energy</measure>
      <time_frame>6-48 months</time_frame>
      <description>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.&#xD;
  Neuropsychological instrument regarding the Energetic domain:&#xD;
  - Questionnaire for mental and physical fatigue (Dutch Multifactor Fatigue Scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Behaviour</measure>
      <time_frame>6-48 months</time_frame>
      <description>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.&#xD;
  Neuropsychological instruments regarding the Behavioural domain:&#xD;
  Neuropsychological test for social cognition (Facial Expressions of Emotion - Stimuli and Tests)&#xD;
  Subscales of a questionnaire for social cognitive symptoms (Dysexecutive Questionnaire - self and proxy)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Affect</measure>
      <time_frame>6-48 months</time_frame>
      <description>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.&#xD;
  Neuropsychological instrument regarding the Affective domain:&#xD;
  - Questionnaire for anxiety and depression (Hospital Anxiety and Depression Scale)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of societal participation</measure>
      <time_frame>6-48 months</time_frame>
      <description>Level of societal participation will be derived from the score on a questionnaire called 'Impact on Participation and Autonomy (IPA)'</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective burden</measure>
      <time_frame>6-48 months</time_frame>
      <description>Subjective burden will be obtained through conducting an anamnesis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Demographic information</measure>
      <time_frame>6-48 months</time_frame>
      <description>Demographic information will be derived from medical records and anamnesis.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>Phase 1</arm_group_label>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Retest Phase 1</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>There is no intervention.</intervention_name>
      <description>There is no intervention.</description>
      <arm_group_label>Phase 1</arm_group_label>
      <arm_group_label>Retest Phase 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          People with Multiple Sclerosis (pwMS).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          In order to be eligible to participate in this study, a patient must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed MS diagnosis (all subtypes);&#xD;
  &#xD;
            -  Age18-70;&#xD;
  &#xD;
            -  Adequate command of the Dutch language.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not being able to participate in a short neuropsychological assessment (NPA) as judged&#xD;
               by the MS clinician and/or investigator;&#xD;
  &#xD;
            -  Presence of any other neurological and/or major psychiatric condition.&#xD;
  &#xD;
          The group of HC's will be matched to the patient group on age and education level.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joke Spikman, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anniek Reinhardt, MSc./Drs.</last_name>
      <phone>+3150 3619431</phone>
      <email>a.reinhardt@umcg.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sandra Rakers, Dr.</last_name>
      <phone>+3150 3612409</phone>
      <email>s.e.rakers@umcg.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Medical Center Groningen (UMCG)</name>
        <address>
          <city>Groningen</city>
          <zip>9700 RB</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anniek Reinhardt, MSc./Drs.</last_name>
        <phone>+3150 3619431</phone>
        <email>a.reinhardt@umcg.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016309
  org study id: NL2023.202315914
  nct id: NCT06016309
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Cognition
  time frame: 6-48 months
  description: 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)
  measure: Energy
  time frame: 6-48 months
  description: 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)
  measure: Behaviour
  time frame: 6-48 months
  description: 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)
  measure: Affect
  time frame: 6-48 months
  description: 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)
  measure: Level of societal participation
  time frame: 6-48 months
  description: Level of societal participation will be derived from the score on a questionnaire called 'Impact on Participation and Autonomy (IPA)'
  measure: Subjective burden
  time frame: 6-48 months
  description: Subjective burden will be obtained through conducting an anamnesis.
  measure: Demographic information
  time frame: 6-48 months
  description: Demographic information will be derived from medical records and anamnesis.
  arm group label: Phase 1
  description: 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.
  arm group label: Retest Phase 1
  description: 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.
  intervention type: Other
  intervention name: There is no intervention.
  description: There is no intervention.
  arm group label: Phase 1
  arm group label: Retest Phase 1
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joke Spikman, Prof. Dr.
  role: Principal Investigator
  affiliation: Department of Neurology - Unit Neuropsychology of the University Medical Center Groningen (UMCG)
  last name: Anniek Reinhardt, MSc./Drs.
  phone: +3150 3619431
  email: a.reinhardt@umcg.nl
  last name: Sandra Rakers, Dr.
  phone: +3150 3612409
  email: s.e.rakers@umcg.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  sharing ipd: Undecided