<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/NCT02185677</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2013/07</org_study_id>
    <nct_id>NCT02185677</nct_id>
  </id_info>
  <brief_title>Cognitive and Behavioral Dysexecutive Syndrome in Multiple System Atrophy</brief_title>
  <acronym>CogAMS</acronym>
  <official_title>Comparison of Cognitive and Behavioral Dysexecutive Syndrome Between Parkinsonian Form and Cerebellar Form of Multiple System Atrophy and Analysis of Correlates With an Imaging Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to compare the score to the Behavioral Dysexecutive&#xD;
      Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and&#xD;
      cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 7&#xD;
      years) and sex .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by&#xD;
      a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and&#xD;
      additional signs. According to the consensus criteria for the diagnosis of MSA, the presence&#xD;
      of dementia is considered an exclusion criteria. However, several studies have reported&#xD;
      cognitive impairment in patients with MSA, dominated by a dysexecutive syndrome. Some studies&#xD;
      have compared the cognitive profile of MSA-P patients and MSA-C but any have studied the&#xD;
      behavioral dysexecutive syndrome in this population. In 2010, the GREFFEX has established&#xD;
      criteria for dysexecutive syndrome and described two distinct parts: the dysexecutive&#xD;
      syndrome and cognitive behavioral dysexecutive syndrome. Our clinical impression is that&#xD;
      according to the type of MSA, the dysexecutive syndrome seems to be different : the MSA-P&#xD;
      patients seem to have a cognitive dysexecutive syndrome and the MSA-C patients a behavioral&#xD;
      dysexecutive syndrome.&#xD;
&#xD;
      We want to compare the BDSI score between MSA-P patients and MSA-C patients matched on&#xD;
      disease duration, age and sex The specific involvement of the cerebellum in behavioral&#xD;
      disorders could explain the behavioral differences experienced by clinicians caring for these&#xD;
      patients but never demonstrated. The presence of these disorders could have an impact on the&#xD;
      relationship between the patient and the caregiver. In addition, few studies have correlated&#xD;
      with cognitive imagery data. Therefore, the exact areas involved in cognitive and behavioral&#xD;
      MSApatients remain poorly understood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2014</start_date>
  <completion_date type="Actual">June 26, 2015</completion_date>
  <primary_completion_date type="Actual">June 25, 2015</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>Behavioral Dysexecutive Syndrome Inventory scores</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the cognitive tests exploring the cognitive dysexecutive syndrome between MSA-P patients and MSA-C patients.</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
    <description>Trail making Test&#xD;
Stroop Test&#xD;
Modfied Card Sorting Test&#xD;
Brixton Test&#xD;
Verbal fluency Test&#xD;
Six Elements Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To research correlations between scores UMSARS and cognitive and behavioral scores for MSA-P patients and MSA-C patients.</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
    <description>Assessment using the Behavioral Dysexecutive Syndrome Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare atrophied brain areas, the anatomic and functional abnormalities of neural networks between MSA-P patients and MSA-C patients.</measure>
    <time_frame>At inclusion (Day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To research correlations between imaging abnormalities and cognitive test performance in MSA patients.</measure>
    <time_frame>At inclusion (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>During 7 days after inclusion</time_frame>
    <description>Sleep analysis :&#xD;
Sleep / wake cycles and sleep fragmentation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Multiple System Atrophy</condition>
  <arm_group>
    <arm_group_label>MSA-P</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>MSA-C</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical evaluation</intervention_name>
    <arm_group_label>MSA-C</arm_group_label>
    <arm_group_label>MSA-P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neuropsychological battery test</intervention_name>
    <arm_group_label>MSA-C</arm_group_label>
    <arm_group_label>MSA-P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <arm_group_label>MSA-C</arm_group_label>
    <arm_group_label>MSA-P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Actigraphy</intervention_name>
    <description>Actigraphy recording will be performed during 7 days after inclusion.</description>
    <arm_group_label>MSA-C</arm_group_label>
    <arm_group_label>MSA-P</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from MSA-P or MSA-C&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients suffering from &quot;probable&quot; MSA according to clinical consensus criteria&#xD;
             (Gilman et al, 2008),&#xD;
&#xD;
          -  Age &gt;30&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Patient covered by the national health system&#xD;
&#xD;
          -  The presence of an informant&#xD;
&#xD;
          -  Blood negative dosage of the hormone béta-hCG for the women old enough to procreate&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  UMSARS IV score &gt; 4 points&#xD;
&#xD;
          -  Pregnant woman (blood positive dosage of the hormone béta-hCG) or breast feeding&#xD;
&#xD;
          -  Patient under tutelage&#xD;
&#xD;
          -  Patient unable to give consent&#xD;
&#xD;
          -  Against indication to perform an MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra FOUBERT-SAMIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rodolphe THIEBAUT, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dysexecutive syndrome</keyword>
  <keyword>multiple system atrophy</keyword>
  <keyword>imaging study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple System Atrophy</mesh_term>
    <mesh_term>Shy-Drager Syndrome</mesh_term>
    <mesh_term>Atrophy</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/NCT02185677
org study id: CHUBX 2013/07
nct id: NCT02185677
lead sponsor: 
has dmc: No
The main objective of the study is to compare the score to the Behavioral Dysexecutive
      Syndrome Inventory (BDSI) between Parkinsonian Multiple system Atrophy MSA-P patients and
      cerebellar Multiple System Atrophy (MSA-C) patients matched on disease duration, age (± 7
      years) and sex .
Multiple system atrophy (MSA) is a rare neurodegenerative disorder which is characterized by
      a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and
      additional signs. According to the consensus criteria for the diagnosis of MSA, the presence
      of dementia is considered an exclusion criteria. However, several studies have reported
      cognitive impairment in patients with MSA, dominated by a dysexecutive syndrome. Some studies
      have compared the cognitive profile of MSA-P patients and MSA-C but any have studied the
      behavioral dysexecutive syndrome in this population. In 2010, the GREFFEX has established
      criteria for dysexecutive syndrome and described two distinct parts: the dysexecutive
      syndrome and cognitive behavioral dysexecutive syndrome. Our clinical impression is that
      according to the type of MSA, the dysexecutive syndrome seems to be different : the MSA-P
      patients seem to have a cognitive dysexecutive syndrome and the MSA-C patients a behavioral
      dysexecutive syndrome.

      We want to compare the BDSI score between MSA-P patients and MSA-C patients matched on
      disease duration, age and sex The specific involvement of the cerebellum in behavioral
      disorders could explain the behavioral differences experienced by clinicians caring for these
      patients but never demonstrated. The presence of these disorders could have an impact on the
      relationship between the patient and the caregiver. In addition, few studies have correlated
      with cognitive imagery data. Therefore, the exact areas involved in cognitive and behavioral
      MSApatients remain poorly understood.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Behavioral Dysexecutive Syndrome Inventory scores
time frame: At inclusion (day 0)
measure: To compare the subscores of the BDSI between MSA-P patients and MSA-C patients.
time frame: At inclusion (Day 0)
measure: To compare the cognitive tests exploring the cognitive dysexecutive syndrome between MSA-P patients and MSA-C patients.
time frame: At inclusion (Day 0)
description: Trail making Test
Stroop Test
Modfied Card Sorting Test
Brixton Test
Verbal fluency Test
Six Elements Test
measure: To research correlations between scores UMSARS and cognitive and behavioral scores for MSA-P patients and MSA-C patients.
time frame: At inclusion (Day 0)
description: Assessment using the Behavioral Dysexecutive Syndrome Inventory
measure: To compare atrophied brain areas, the anatomic and functional abnormalities of neural networks between MSA-P patients and MSA-C patients.
time frame: At inclusion (Day 0)
measure: To research correlations between imaging abnormalities and cognitive test performance in MSA patients.
time frame: At inclusion (day 0)
measure: Actigraphy
time frame: During 7 days after inclusion
description: Sleep analysis :
Sleep / wake cycles and sleep fragmentation
arm group label: MSA-P
arm group label: MSA-C
intervention type: Other
intervention name: Clinical evaluation
arm group label: MSA-C
arm group label: MSA-P
intervention type: Other
intervention name: neuropsychological battery test
arm group label: MSA-C
arm group label: MSA-P
intervention type: Other
intervention name: MRI
arm group label: MSA-C
arm group label: MSA-P
intervention type: Other
intervention name: Actigraphy
description: Actigraphy recording will be performed during 7 days after inclusion.
arm group label: MSA-C
arm group label: MSA-P
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandra FOUBERT-SAMIER, MD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Rodolphe THIEBAUT, MD, PhD
role: Study Chair
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple System Atrophy
mesh term: Shy-Drager Syndrome
mesh term: Atrophy