<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/NCT04455074</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.116</org_study_id>
    <secondary_id>2020-A00862-37</secondary_id>
    <nct_id>NCT04455074</nct_id>
  </id_info>
  <brief_title>Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))</brief_title>
  <acronym>EFN-VALID</acronym>
  <official_title>French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in&#xD;
      Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of&#xD;
      non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD.&#xD;
      The main goal of this project is to validate the NF-scale in french language in a multicenter&#xD;
      approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the&#xD;
      off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral&#xD;
      addictions, mania, and psychosis might occur during the on-medication condition. Early&#xD;
      diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often&#xD;
      under-recognized by patients or misdiagnosed by physicians due to the lack of specific&#xD;
      assessment tools. The NFS is composed of 20 items among which ten measure the &quot;ON&#xD;
      neuropsychological state&quot; and ten, the &quot;OFF neuropsychological state&quot;. It provides two&#xD;
      sub-scores (one ON and one OFF) with a maximal total score of 30.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">March 23, 2023</completion_date>
  <primary_completion_date type="Actual">March 23, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>validation of FN scale: realiability</measure>
    <time_frame>2 months</time_frame>
    <description>EFN score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>validation of FN scale: internal consistency</measure>
    <time_frame>4 hours</time_frame>
    <description>EFN score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>validation of FN scale: measurement error</measure>
    <time_frame>2 months</time_frame>
    <description>test-retest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>validation of FN scale: structural validity</measure>
    <time_frame>4 hours</time_frame>
    <description>EFN score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>validation of FN scale: responsiveness</measure>
    <time_frame>4 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>validation of FN scale: acceptability</measure>
    <time_frame>4 hours</time_frame>
    <description>EFN score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics 1</measure>
    <time_frame>4 hours</time_frame>
    <description>MDS-UPDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics 2</measure>
    <time_frame>4 hours</time_frame>
    <description>Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics 3</measure>
    <time_frame>4 hours</time_frame>
    <description>stage of PD (Hoehn &amp; Yahr stage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (4)</measure>
    <time_frame>4 hours</time_frame>
    <description>cognitif state (Montreal cognitive assessment - MoCA test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (5)</measure>
    <time_frame>4 hours</time_frame>
    <description>Impulsive-Compulsive Disorders (QUIP-RS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (6)</measure>
    <time_frame>4 hours</time_frame>
    <description>Dopamine-dependant behavior (ACDD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (7)</measure>
    <time_frame>4 hours</time_frame>
    <description>Wearing off (QUICK questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (8)</measure>
    <time_frame>4 hours</time_frame>
    <description>Depression (Beck depression inventory BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation of EFN scores with socio-clinical characteristics (9)</measure>
    <time_frame>4 hours</time_frame>
    <description>Evalulation of impulsive behavior (UPSS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Fluctuating Mood Symptoms</condition>
  <arm_group>
    <arm_group_label>PD patients with motor fluctuations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FN scale auto-questionnaire</intervention_name>
    <description>Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.</description>
    <arm_group_label>PD patients with motor fluctuations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic Parkinson's disease&#xD;
&#xD;
          -  presence of motor fluctuations, requiring a levodopa test&#xD;
&#xD;
          -  french native speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia (MoCa &lt; 24)&#xD;
&#xD;
          -  Parkinson syndrome other than idiopathic PD&#xD;
&#xD;
          -  people excluded according to french law (including pregnant women or nursing mothers,&#xD;
             ...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena MORO, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80 054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux-Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33 076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils Lyon (HCL)</name>
      <address>
        <city>Lyon</city>
        <zip>69 677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>April 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 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>Parkinson Disease</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/NCT04455074
org study id: 38RC20.116
secondary id: 2020-A00862-37
nct id: NCT04455074
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in
      Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of
      non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD.
      The main goal of this project is to validate the NF-scale in french language in a multicenter
      approach.
Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the
      off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral
      addictions, mania, and psychosis might occur during the on-medication condition. Early
      diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often
      under-recognized by patients or misdiagnosed by physicians due to the lack of specific
      assessment tools. The NFS is composed of 20 items among which ten measure the "ON
      neuropsychological state" and ten, the "OFF neuropsychological state". It provides two
      sub-scores (one ON and one OFF) with a maximal total score of 30.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: validation of FN scale: realiability
time frame: 2 months
description: EFN score
measure: validation of FN scale: internal consistency
time frame: 4 hours
description: EFN score
measure: validation of FN scale: measurement error
time frame: 2 months
description: test-retest
measure: validation of FN scale: structural validity
time frame: 4 hours
description: EFN score
measure: validation of FN scale: responsiveness
time frame: 4 hours
measure: validation of FN scale: acceptability
time frame: 4 hours
description: EFN score
measure: correlation of EFN scores with socio-clinical characteristics 1
time frame: 4 hours
description: MDS-UPDRS
measure: correlation of EFN scores with socio-clinical characteristics 2
time frame: 4 hours
description: Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)
measure: correlation of EFN scores with socio-clinical characteristics 3
time frame: 4 hours
description: stage of PD (Hoehn & Yahr stage)
measure: correlation of EFN scores with socio-clinical characteristics (4)
time frame: 4 hours
description: cognitif state (Montreal cognitive assessment - MoCA test)
measure: correlation of EFN scores with socio-clinical characteristics (5)
time frame: 4 hours
description: Impulsive-Compulsive Disorders (QUIP-RS)
measure: correlation of EFN scores with socio-clinical characteristics (6)
time frame: 4 hours
description: Dopamine-dependant behavior (ACDD)
measure: correlation of EFN scores with socio-clinical characteristics (7)
time frame: 4 hours
description: Wearing off (QUICK questionnaire)
measure: correlation of EFN scores with socio-clinical characteristics (8)
time frame: 4 hours
description: Depression (Beck depression inventory BDI-II)
measure: correlation of EFN scores with socio-clinical characteristics (9)
time frame: 4 hours
description: Evalulation of impulsive behavior (UPSS)
arm group label: PD patients with motor fluctuations
arm group type: Experimental
description: FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition
intervention type: Other
intervention name: FN scale auto-questionnaire
description: Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.
arm group label: PD patients with motor fluctuations
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elena MORO, MD PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease