<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/NCT03272230</url>
  </required_header>
  <id_info>
    <org_study_id>C16-87</org_study_id>
    <secondary_id>2017-A00416-47</secondary_id>
    <nct_id>NCT03272230</nct_id>
  </id_info>
  <brief_title>Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System</brief_title>
  <acronym>ECOCAPTURE</acronym>
  <official_title>Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</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>
      Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.&#xD;
&#xD;
      So, the investigators propose a behavioral approach for assessing apathy, to obtain a&#xD;
      quantifiable and objective signature of reduced goal-directed behavior by directly observing&#xD;
      a patient in a real-life situation.&#xD;
&#xD;
      ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped&#xD;
      with data acquisition system based on video and sensors that track a participant's behavior.&#xD;
&#xD;
      The primary objective of this trial is to create a diagnostic tool for apathy, based on the&#xD;
      video and sensors metrics.&#xD;
&#xD;
      A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS)&#xD;
      to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia&#xD;
      and coupling between motivation and action).&#xD;
&#xD;
      Another secondary objective aims to specify the pathophysiological mechanisms of apathy,&#xD;
      corresponding to cognitive and behavioral processes, neural bases and neurohormonal&#xD;
      mechanisms. The definition of pathophysiological mechanisms will allow the classification of&#xD;
      apathetic patients (or several forms of apathy) and indicate which mechanism (s) best&#xD;
      explains the apathy in a given patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot study ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015) applied to a group of&#xD;
      participants with the behavioural variant of frontotemporal lobar degeneration (bvFTLD)&#xD;
      matched for age, gender and level of education to healthy participants (n=7 per group). This&#xD;
      pilot validated the concept of ECOCAPTURE.&#xD;
&#xD;
      The purpose of this trial is to continue the implementation of the ECOCAPTURE tool, extending&#xD;
      it to three pathological models: bvFTLD, Parkinson's disease and depression.&#xD;
&#xD;
      The objectives aim to assess behavior directed towards a goal and identify apathy, analyze&#xD;
      data to obtain a behavioral signature of apathy and to produce more finely differentiated&#xD;
      apathetic patients profiles by specifying the pathophysiological mechanisms (cognitive&#xD;
      mechanisms, as well as the neural bases and the neuro-hormonal mechanisms) underlying apathy.&#xD;
&#xD;
      The investigators use multimodal recording tools to track behavior. A multiple-camera system&#xD;
      is set up with video coverage of the whole room. A sensor (Move II, Movisens, Karlsruhe,&#xD;
      Germany) fixed to the subject's hip, records data such as 3D acceleration, barometric&#xD;
      pressure and temperature. From these data, secondary parameters like activity class, body&#xD;
      position, steps, energy expenditure and metabolic equivalents are calculated. Video data&#xD;
      analysis is performed with The Observer XT software (Noldus, Wageningen, The Netherlands)&#xD;
      using an ethogram to identify the frequency and duration of behaviors. For 10 min, during the&#xD;
      experimental session, participants ware eye-tracking glasses (ETG 2w, SMI, Teltow, Germany)&#xD;
      that record natural gaze behavior.&#xD;
&#xD;
      Metrics built from raw data (video, sensors) are analyzed to reveal a behavioral signature of&#xD;
      apathy, highlighting a quantitative reduction in goal-directed behavior.&#xD;
&#xD;
      The study takes place on two visits (one per day). It consists of the observation phase, a&#xD;
      neuropsychological assessment, experimental tasks, some of which are computerized, an MRI&#xD;
      examination and finally a blood test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of each behavior from the ethogram</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the video recording and The Observer NOLDUS software] integer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of each behavior from the ethogram</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the video recording and The Observer NOLDUS software] integer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of each behavior from the ethogram</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the video recording and The Observer NOLDUS software] integer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of different behaviors</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the video recording and The Observer NOLDUS software] integer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity classes</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] lying, sitting, ...</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body positions</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] lying left, ...</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy expenditure</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] kcal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MET</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steps</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] Counting steps.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceleration intensity</measure>
    <time_frame>45 min</time_frame>
    <description>[Provided by the MOVE MOVISENS sensor] g.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pupil Diameter x</measure>
    <time_frame>10 min</time_frame>
    <description>[Provided by the eye-tracking glasses SMI ETG 2w] mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pupil Diameter y</measure>
    <time_frame>10 min</time_frame>
    <description>[Provided by the eye-tracking glasses SMI ETG 2w] mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICM_APATHY_TASKS</measure>
    <time_frame>At day 1</time_frame>
    <description>ICM_APATHY_TASKS global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MMSE</measure>
    <time_frame>At day 1</time_frame>
    <description>[Mini Mental State Exam] MMSE global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MATTIS</measure>
    <time_frame>At day 1</time_frame>
    <description>[Mattis Dementia Rating Scale ] MATTIS global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NART</measure>
    <time_frame>At day 1</time_frame>
    <description>[National Adult Reading Test] NART IQ (global score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BREF (FAB english)</measure>
    <time_frame>At day 1</time_frame>
    <description>[Frontal Assessment Battery] BREF global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAYLING</measure>
    <time_frame>At day 1</time_frame>
    <description>[Hayling Sentence Completion test] ] HAYLING global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAD</measure>
    <time_frame>At day 1</time_frame>
    <description>[Hospital Anxiety and Depression Scale] ]HAD global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gray matter volume</measure>
    <time_frame>At day 2</time_frame>
    <description>[MRI analysis- Brain segmentation] mm3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White matter volume</measure>
    <time_frame>At day 2</time_frame>
    <description>[MRI analysis- Brain segmentation] mm3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Spinal Fluid volume</measure>
    <time_frame>At day 2</time_frame>
    <description>[MRI analysis- Brain segmentation] mm3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain lesion localization</measure>
    <time_frame>At day 2</time_frame>
    <description>[MRI analysis- Brain segmentation] Talairach x,y,z coordinates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>At day 1</time_frame>
    <description>Hormonal result [Interleukin-6] pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leptin</measure>
    <time_frame>At day 1</time_frame>
    <description>Hormonal result [Leptin] ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>At day 1</time_frame>
    <description>Hormonal result [Blood adiponectin level)] mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>At day 1</time_frame>
    <description>Hormonal result [Fasting Insulin] mUI/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-Peptide</measure>
    <time_frame>At day 1</time_frame>
    <description>Diabetic result [Fasting C-Peptide level] µg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FPG</measure>
    <time_frame>At day 1</time_frame>
    <description>Diabetic result [Fasting Plasma Glucose] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>At day 1</time_frame>
    <description>Diabetic result [Glycated Hemoglobin] %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K+</measure>
    <time_frame>At day 1</time_frame>
    <description>Ionogram result [Potassium] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric acid</measure>
    <time_frame>At day 1</time_frame>
    <description>Ionogram result [Uric acid] µmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>At day 1</time_frame>
    <description>Ionogram result [Creatinine] µmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Protein</measure>
    <time_frame>At day 1</time_frame>
    <description>Ionogram result [Total protein] g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>At day 1</time_frame>
    <description>Inflammatory result [C-reactive protein] mG/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AST</measure>
    <time_frame>At day 1</time_frame>
    <description>Hepatic result [Aspartate aminotransferase] U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT</measure>
    <time_frame>At day 1</time_frame>
    <description>Hepatic result [Alanine aminotransferase] U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GGT</measure>
    <time_frame>At day 1</time_frame>
    <description>Hepatic result [Gamma-glutamyltransferase] U/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [Total cholesterol] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [Triglycerides] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [High-density lipoprotein cholesterol] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [Low-density lipoprotein cholesterol] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycerol</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [Plasma glycerol concentration] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FFAs</measure>
    <time_frame>At day 1</time_frame>
    <description>Lipidic result [Plasma free fatty acids] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TSH</measure>
    <time_frame>At day 1</time_frame>
    <description>Thyroid result [Thyroid-stimulating hormone blood test] mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAS</measure>
    <time_frame>At day 1</time_frame>
    <description>[Dimensional Apathy Scale] DAS global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STARKSTEIN (SAS)</measure>
    <time_frame>At day 1</time_frame>
    <description>[Starkstein Apathy Scale (SAS)] SAS global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MADRS</measure>
    <time_frame>At day 1</time_frame>
    <description>[Montgomery-Åsberg Depression Rating Scale] MADRS global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EBI</measure>
    <time_frame>At day 1</time_frame>
    <description>[Eating Behavior Inventory] EBI global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACDD</measure>
    <time_frame>At day 1</time_frame>
    <description>[Autoévaluation des Comportements Dopamine Dépendants] ACDD answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QUIP</measure>
    <time_frame>At day 1</time_frame>
    <description>[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease] QUIP answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS-11</measure>
    <time_frame>At day 1</time_frame>
    <description>[Barratt Impulsiveness Scale] BIS-11 global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-SEA</measure>
    <time_frame>At day 1</time_frame>
    <description>[Mini Social cognition and Emotional Assesment] Mini-SEA global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STROOP</measure>
    <time_frame>At day 1</time_frame>
    <description>[STROOP Test] STROOP global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECMP</measure>
    <time_frame>At day 1</time_frame>
    <description>[Evaluation Comportementale dans la Maladie de Parkinson] ECMP answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QUIP-RS</measure>
    <time_frame>At day 1</time_frame>
    <description>[Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale] QUIP-RS global score</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Apathy</condition>
  <condition>Frontotemporal Dementia</condition>
  <condition>Parkinson Disease</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>bvFTD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially especially patients diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to the Rascovsky criteria (Rascovsky et al. 2011).&#xD;
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy age, sex and education matched controls&#xD;
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992).&#xD;
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially especially patients diagnosed with depression (Major Depressive Disorder, DSM-IV).&#xD;
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992). ICDs are closely related to use of dopaminergic medications.&#xD;
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ECOCAPTURE</intervention_name>
    <description>45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive and Behavioral experimental tasks</intervention_name>
    <description>Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neuropsychological assessment</intervention_name>
    <description>MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ICM_APATHY_TASKS</intervention_name>
    <description>Apathy experimental task</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Neurohormonal mechanisms</intervention_name>
    <description>Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage</description>
    <arm_group_label>Depression</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>bvFTD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Supplementary Neuropsychological Assessment - Parkinson's Disease</intervention_name>
    <description>ACDD / QUIP / BIS-11 / ECMP / QUIP-RS</description>
    <arm_group_label>Parkinson's disease with Impulse Control Disorders (ICDs)</arm_group_label>
    <arm_group_label>Parkinson's disease without Impulse Control Disorders (ICDs)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All groups:&#xD;
&#xD;
          -  Ability to give informed consent for study procedures&#xD;
&#xD;
          -  Ability to understand study instructions and to realize the cognitive tasks&#xD;
&#xD;
          -  Person with health insurance&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  MMS&gt;20&#xD;
&#xD;
          -  Absence of another neurological or psychiatric disease&#xD;
&#xD;
          -  Presence of a caregiver&#xD;
&#xD;
          -  We will recruit three groups of patients:&#xD;
&#xD;
               -  diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to&#xD;
                  the Rascovsky criteria (Rascovsky et al. 2011)&#xD;
&#xD;
               -  diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992)&#xD;
&#xD;
                    -  Sub-group 1: Parkinson's disease with Impulse Control Disorders (ICDs)&#xD;
&#xD;
                    -  Sub-group 2: Parkinson's disease without Impulse Control Disorders (ICDs)&#xD;
&#xD;
               -  diagnosed with depression (Major Depressive Disorder, DSM-IV)&#xD;
&#xD;
        Healthy age,sex, education-matched controls:&#xD;
&#xD;
          -  MMS&gt;27&#xD;
&#xD;
          -  Absence of neurological or psychiatric disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Standard contraindications to MRI&#xD;
&#xD;
          -  Inability to understand study instructions&#xD;
&#xD;
          -  Person mentioned in the article L.1121-5 to L. 1121-8 and L. 1122-12 of the French&#xD;
             Public Health Code&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard LEVY, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bénédicte M BATRANCOURT, PhD</last_name>
    <phone>(33-6) 60 44 79 79</phone>
    <email>benedicte.batrancourt@upmc.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Armelle RAMETTI-LACROUX, PhD</last_name>
    <phone>(33-1) 42 16 55 20</phone>
    <email>armelle.ramettilacroux@icm-institute.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ICM / Pitié-Salpêtrière Hospital AP-HP / CIC</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armelle RAMETTI-LACROUX, PhD</last_name>
      <phone>(33-1) 42 16 55 20</phone>
      <email>armelle.ramettilacroux@icm-institute.org</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apathy</keyword>
  <keyword>Goal-directed behavior</keyword>
  <keyword>Assessment</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Sensor</keyword>
  <keyword>Ecological condition</keyword>
  <keyword>Neurological disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03272230
org study id: C16-87
secondary id: 2017-A00416-47
nct id: NCT03272230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.

      So, the investigators propose a behavioral approach for assessing apathy, to obtain a
      quantifiable and objective signature of reduced goal-directed behavior by directly observing
      a patient in a real-life situation.

      ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped
      with data acquisition system based on video and sensors that track a participant's behavior.

      The primary objective of this trial is to create a diagnostic tool for apathy, based on the
      video and sensors metrics.

      A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS)
      to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia
      and coupling between motivation and action).

      Another secondary objective aims to specify the pathophysiological mechanisms of apathy,
      corresponding to cognitive and behavioral processes, neural bases and neurohormonal
      mechanisms. The definition of pathophysiological mechanisms will allow the classification of
      apathetic patients (or several forms of apathy) and indicate which mechanism (s) best
      explains the apathy in a given patient.
A pilot study ECOCAPTURE (ClinicalTrials.gov/NCT02496312, 2015) applied to a group of
      participants with the behavioural variant of frontotemporal lobar degeneration (bvFTLD)
      matched for age, gender and level of education to healthy participants (n=7 per group). This
      pilot validated the concept of ECOCAPTURE.

      The purpose of this trial is to continue the implementation of the ECOCAPTURE tool, extending
      it to three pathological models: bvFTLD, Parkinson's disease and depression.

      The objectives aim to assess behavior directed towards a goal and identify apathy, analyze
      data to obtain a behavioral signature of apathy and to produce more finely differentiated
      apathetic patients profiles by specifying the pathophysiological mechanisms (cognitive
      mechanisms, as well as the neural bases and the neuro-hormonal mechanisms) underlying apathy.

      The investigators use multimodal recording tools to track behavior. A multiple-camera system
      is set up with video coverage of the whole room. A sensor (Move II, Movisens, Karlsruhe,
      Germany) fixed to the subject's hip, records data such as 3D acceleration, barometric
      pressure and temperature. From these data, secondary parameters like activity class, body
      position, steps, energy expenditure and metabolic equivalents are calculated. Video data
      analysis is performed with The Observer XT software (Noldus, Wageningen, The Netherlands)
      using an ethogram to identify the frequency and duration of behaviors. For 10 min, during the
      experimental session, participants ware eye-tracking glasses (ETG 2w, SMI, Teltow, Germany)
      that record natural gaze behavior.

      Metrics built from raw data (video, sensors) are analyzed to reveal a behavioral signature of
      apathy, highlighting a quantitative reduction in goal-directed behavior.

      The study takes place on two visits (one per day). It consists of the observation phase, a
      neuropsychological assessment, experimental tasks, some of which are computerized, an MRI
      examination and finally a blood test.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Occurrence of each behavior from the ethogram
time frame: 45 min
description: [Provided by the video recording and The Observer NOLDUS software] integer.
measure: Frequency of each behavior from the ethogram
time frame: 45 min
description: [Provided by the video recording and The Observer NOLDUS software] integer.
measure: Duration of each behavior from the ethogram
time frame: 45 min
description: [Provided by the video recording and The Observer NOLDUS software] integer.
measure: Number of different behaviors
time frame: 45 min
description: [Provided by the video recording and The Observer NOLDUS software] integer.
measure: Activity classes
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] lying, sitting, ...
measure: Body positions
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] lying left, ...
measure: Energy expenditure
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] kcal.
measure: MET
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] The Metabolic Equivalent of Task: MET level.
measure: Steps
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] Counting steps.
measure: Acceleration intensity
time frame: 45 min
description: [Provided by the MOVE MOVISENS sensor] g.
measure: Pupil Diameter x
time frame: 10 min
description: [Provided by the eye-tracking glasses SMI ETG 2w] mm.
measure: Pupil Diameter y
time frame: 10 min
description: [Provided by the eye-tracking glasses SMI ETG 2w] mm.
measure: ICM_APATHY_TASKS
time frame: At day 1
description: ICM_APATHY_TASKS global score
measure: MMSE
time frame: At day 1
description: [Mini Mental State Exam] MMSE global score
measure: MATTIS
time frame: At day 1
description: [Mattis Dementia Rating Scale ] MATTIS global score
measure: NART
time frame: At day 1
description: [National Adult Reading Test] NART IQ (global score)
measure: BREF (FAB english)
time frame: At day 1
description: [Frontal Assessment Battery] BREF global score
measure: HAYLING
time frame: At day 1
description: [Hayling Sentence Completion test] ] HAYLING global score
measure: HAD
time frame: At day 1
description: [Hospital Anxiety and Depression Scale] ]HAD global score
measure: Gray matter volume
time frame: At day 2
description: [MRI analysis- Brain segmentation] mm3
measure: White matter volume
time frame: At day 2
description: [MRI analysis- Brain segmentation] mm3
measure: Cerebral Spinal Fluid volume
time frame: At day 2
description: [MRI analysis- Brain segmentation] mm3
measure: Brain lesion localization
time frame: At day 2
description: [MRI analysis- Brain segmentation] Talairach x,y,z coordinates
measure: IL-6
time frame: At day 1
description: Hormonal result [Interleukin-6] pg/mL
measure: Leptin
time frame: At day 1
description: Hormonal result [Leptin] ng/mL
measure: Adiponectin
time frame: At day 1
description: Hormonal result [Blood adiponectin level)] mg/L
measure: Insulin
time frame: At day 1
description: Hormonal result [Fasting Insulin] mUI/L
measure: C-Peptide
time frame: At day 1
description: Diabetic result [Fasting C-Peptide level] µg/L
measure: FPG
time frame: At day 1
description: Diabetic result [Fasting Plasma Glucose] mmol/L
measure: HbA1C
time frame: At day 1
description: Diabetic result [Glycated Hemoglobin] %
measure: K+
time frame: At day 1
description: Ionogram result [Potassium] mmol/L
measure: Uric acid
time frame: At day 1
description: Ionogram result [Uric acid] µmol/L
measure: Creatinine
time frame: At day 1
description: Ionogram result [Creatinine] µmol/L
measure: Total Protein
time frame: At day 1
description: Ionogram result [Total protein] g/L
measure: CRP
time frame: At day 1
description: Inflammatory result [C-reactive protein] mG/L
measure: AST
time frame: At day 1
description: Hepatic result [Aspartate aminotransferase] U/L
measure: ALT
time frame: At day 1
description: Hepatic result [Alanine aminotransferase] U/L
measure: GGT
time frame: At day 1
description: Hepatic result [Gamma-glutamyltransferase] U/L
measure: Cholesterol
time frame: At day 1
description: Lipidic result [Total cholesterol] mmol/L
measure: Triglycerides
time frame: At day 1
description: Lipidic result [Triglycerides] mmol/L
measure: HDL cholesterol
time frame: At day 1
description: Lipidic result [High-density lipoprotein cholesterol] mmol/L
measure: LDL cholesterol
time frame: At day 1
description: Lipidic result [Low-density lipoprotein cholesterol] mmol/L
measure: Glycerol
time frame: At day 1
description: Lipidic result [Plasma glycerol concentration] mmol/L
measure: FFAs
time frame: At day 1
description: Lipidic result [Plasma free fatty acids] mmol/L
measure: TSH
time frame: At day 1
description: Thyroid result [Thyroid-stimulating hormone blood test] mmol/L
measure: DAS
time frame: At day 1
description: [Dimensional Apathy Scale] DAS global score
measure: STARKSTEIN (SAS)
time frame: At day 1
description: [Starkstein Apathy Scale (SAS)] SAS global score
measure: MADRS
time frame: At day 1
description: [Montgomery-Åsberg Depression Rating Scale] MADRS global score
measure: EBI
time frame: At day 1
description: [Eating Behavior Inventory] EBI global score
measure: ACDD
time frame: At day 1
description: [Autoévaluation des Comportements Dopamine Dépendants] ACDD answers
measure: QUIP
time frame: At day 1
description: [Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease] QUIP answers
measure: BIS-11
time frame: At day 1
description: [Barratt Impulsiveness Scale] BIS-11 global score
measure: Mini-SEA
time frame: At day 1
description: [Mini Social cognition and Emotional Assesment] Mini-SEA global score
measure: STROOP
time frame: At day 1
description: [STROOP Test] STROOP global score
measure: ECMP
time frame: At day 1
description: [Evaluation Comportementale dans la Maladie de Parkinson] ECMP answers
measure: QUIP-RS
time frame: At day 1
description: [Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale] QUIP-RS global score
arm group label: bvFTD
arm group type: Experimental
description: Initially especially patients diagnosed with behavioral variant frontotemporal dementia (bvFTD) according to the Rascovsky criteria (Rascovsky et al. 2011).
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms
arm group label: Healthy control
arm group type: Experimental
description: Healthy age, sex and education matched controls
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group type: Experimental
description: Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992).
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms
arm group label: Depression
arm group type: Experimental
description: Initially especially patients diagnosed with depression (Major Depressive Disorder, DSM-IV).
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / MRI / Neurohormonal mechanisms
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group type: Experimental
description: Initially especially patients diagnosed with idiopathic Parkinson's disease (Hughes et al. 1992). ICDs are closely related to use of dopaminergic medications.
ECOCAPTURE / ICM_APATHY_TASKS / Cognitive and Behavioral experimental tasks / Neuropsychological assessment / Supplementary Neuropsychological assessment - Parkinson's disease / MRI / Neurohormonal mechanisms
intervention type: Behavioral
intervention name: ECOCAPTURE
description: 45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Behavioral
intervention name: Cognitive and Behavioral experimental tasks
description: Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Diagnostic Test
intervention name: Neuropsychological assessment
description: MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Behavioral
intervention name: ICM_APATHY_TASKS
description: Apathy experimental task
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Other
intervention name: MRI
description: T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Biological
intervention name: Neurohormonal mechanisms
description: Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
arm group label: Depression
arm group label: Healthy control
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
arm group label: bvFTD
intervention type: Diagnostic Test
intervention name: Supplementary Neuropsychological Assessment - Parkinson's Disease
description: ACDD / QUIP / BIS-11 / ECMP / QUIP-RS
arm group label: Parkinson's disease with Impulse Control Disorders (ICDs)
arm group label: Parkinson's disease without Impulse Control Disorders (ICDs)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard LEVY, MD, PhD
role: Principal Investigator
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
last name: Bénédicte M BATRANCOURT, PhD
phone: (33-6) 60 44 79 79
email: benedicte.batrancourt@upmc.fr
last name: Armelle RAMETTI-LACROUX, PhD
phone: (33-1) 42 16 55 20
email: armelle.ramettilacroux@icm-institute.org
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Depression
sharing ipd: No