<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/NCT03288090</url>
  </required_header>
  <id_info>
    <org_study_id>Béjot 2017</org_study_id>
    <nct_id>NCT03288090</nct_id>
  </id_info>
  <brief_title>Evaluate the Frequency of Fatigue After Cerebral Infarction</brief_title>
  <acronym>Fatigue AVC</acronym>
  <official_title>Fatigue After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among&#xD;
      these sequelae, fatigue is frequently reported by patients. It is therefore important for&#xD;
      doctors to understand why patients suffer from fatigue after cerebral infarction and to&#xD;
      determine whether treatments given for the cerebral infarction may have an impact on this&#xD;
      fatigue.&#xD;
&#xD;
      The aim of this research was to study the frequency of fatigue after cerebral infarction, the&#xD;
      associated factors, in particular the impact of treatments administered in the acute phase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">November 22, 2018</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</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>Fatigue evaluated using the Fatigue Severity Scale (FSS)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Symptomatic Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>Treated</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-treated</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FSS: Fatigue Severity Scale</intervention_name>
    <description>Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).</description>
    <arm_group_label>Non-treated</arm_group_label>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuropsychological evaluation battery</intervention_name>
    <description>A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.</description>
    <arm_group_label>Non-treated</arm_group_label>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other functional scores</intervention_name>
    <description>Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale</description>
    <arm_group_label>Non-treated</arm_group_label>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cerebral infarction dating back one week at most&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting recent symptomatic cerebral infarction (&lt; 1 week) defined&#xD;
             according to World Health Organization (WHO) criteria and hospitalised at the Stroke&#xD;
             Unit in Dijon University.&#xD;
&#xD;
          -  Patients aged 18 years or older.&#xD;
&#xD;
          -  Patients who have been informed about the study, or their person of trust for patients&#xD;
             unable to express their consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients (or their person of trust) who refuse to participate in the study.&#xD;
&#xD;
          -  Subjects in custody.&#xD;
&#xD;
          -  Patients presenting prior co-morbidity as a cause of significant fatigue in the&#xD;
             opinion of the investigator&#xD;
&#xD;
          -  Patients with dementia or aphasia before the stroke&#xD;
&#xD;
          -  Patients (or their person of trust) who may be difficult to contact by telephone&#xD;
             during the follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</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>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03288090
org study id: Béjot 2017
nct id: NCT03288090
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among
      these sequelae, fatigue is frequently reported by patients. It is therefore important for
      doctors to understand why patients suffer from fatigue after cerebral infarction and to
      determine whether treatments given for the cerebral infarction may have an impact on this
      fatigue.

      The aim of this research was to study the frequency of fatigue after cerebral infarction, the
      associated factors, in particular the impact of treatments administered in the acute phase.
observational model: Cohort
time perspective: Prospective
measure: Fatigue evaluated using the Fatigue Severity Scale (FSS)
time frame: 6 months
arm group label: Treated
arm group label: Non-treated
intervention type: Other
intervention name: FSS: Fatigue Severity Scale
description: Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).
arm group label: Non-treated
arm group label: Treated
intervention type: Other
intervention name: Neuropsychological evaluation battery
description: A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
arm group label: Non-treated
arm group label: Treated
intervention type: Other
intervention name: Other functional scores
description: Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale
arm group label: Non-treated
arm group label: Treated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Infarction
mesh term: Infarction