<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/NCT04440644</url>
  </required_header>
  <id_info>
    <org_study_id>CE 2320</org_study_id>
    <nct_id>NCT04440644</nct_id>
  </id_info>
  <brief_title>Italian Validation of the Beaumont Behavioural Inventory (BBI)</brief_title>
  <acronym>BBI</acronym>
  <official_title>Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral&#xD;
      dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy,&#xD;
      disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary&#xD;
      changes [Strong et al., 2017].&#xD;
&#xD;
      The Beaumont Behavioural Inventory (BBI) [Elamin et al., 2017] is a questionnaire designed&#xD;
      for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at&#xD;
      both validating the BBI in an Italian ALS population and determining normative cut-off values&#xD;
      of the instrument.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2019</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Beaumont Behavioural Inventory</measure>
    <time_frame>2 years</time_frame>
    <description>Psychometrics</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">190</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>patients with amyotrophic lateral sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>healthy control participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BBI</intervention_name>
    <description>administration of psychometric test</description>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subject with amyotrophic lateral sclerosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  possible, probable or definite ALS according to El Escorial revised criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal,&#xD;
             neurological or psychiatric disorder or any other major concurrent illness that in the&#xD;
             opinion of the investigator could interfere with the interpretation of the study&#xD;
             results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ICS Maugeri</name>
      <address>
        <city>Milano</city>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chio A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler Frontotemporal Degener. 2022 Feb;23(1-2):81-86. doi: 10.1080/21678421.2021.1946085. Epub 2021 Jul 19.</citation>
    <PMID>34279169</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ALS; frontotemporal degeneration; behavioural changes.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04440644
org study id: CE 2320
nct id: NCT04440644
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral
      dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy,
      disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary
      changes [Strong et al., 2017].

      The Beaumont Behavioural Inventory (BBI) [Elamin et al., 2017] is a questionnaire designed
      for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at
      both validating the BBI in an Italian ALS population and determining normative cut-off values
      of the instrument.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Beaumont Behavioural Inventory
time frame: 2 years
description: Psychometrics
arm group label: Patients
description: patients with amyotrophic lateral sclerosis
arm group label: Healthy control
description: healthy control participants
intervention type: Behavioral
intervention name: BBI
description: administration of psychometric test
arm group label: Healthy control
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
citation: Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chio A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler Frontotemporal Degener. 2022 Feb;23(1-2):81-86. doi: 10.1080/21678421.2021.1946085. Epub 2021 Jul 19.
PMID: 34279169
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis