<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/NCT03293537</url>
  </required_header>
  <id_info>
    <org_study_id>Biomarker and Apathy</org_study_id>
    <nct_id>NCT03293537</nct_id>
  </id_info>
  <brief_title>Dementia Associated Apathy.</brief_title>
  <official_title>Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zurich University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zurich University of Applied Sciences</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>
      We want to determine if patients with dementia show any kind of emotion while they look at a&#xD;
      defined selection of photos. These are photos taken from a international image-platform and&#xD;
      mixed with photos (biographic) that show personal objects, personal events, etc.&#xD;
&#xD;
      While the photos will be presented each a few seconds the skin conductance and the heart rate&#xD;
      will be measured. We want to find out if there is any emotion measurable while showing the&#xD;
      photos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The lack of overt behaviour in individuals exhibiting dementia-associated apathy is not only&#xD;
      stressful to family members and caregivers, it is also a major challenge for medical and&#xD;
      nursing staff. Knowing whether apathy arises from an impaired function of the neural network&#xD;
      of affect due to neurodegenerative processes accompanying dementia provides a neural&#xD;
      explanation of this condition. Somatic indicators of affective responses (e.g., changes in&#xD;
      skin conductance, or heart rate) are an effective means to uncover covert emotional responses&#xD;
      in nursing home residents suffering from dementia associated apathy.&#xD;
&#xD;
      The overall objective is to determine whether dementia associated apathy is the result of an&#xD;
      impaired functioning of the neural macro-network of affect. We want to compare the&#xD;
      quantitative change in physiological parameters for each image category between individuals&#xD;
      of the two subgroups: 1. Individual with dementia only and 2.individuals with dementia and&#xD;
      dementia-associated apathy.&#xD;
&#xD;
      The primary objective is to uncover a covert emotional response using changes in skin&#xD;
      conductance in patients with dementia and patients with dementia + dementia associated&#xD;
      apathy.&#xD;
&#xD;
      The secondary objective is to uncover a covert emotional response using changes in the heart&#xD;
      rate in patients with dementia and patients with dementia + dementia associated apathy.&#xD;
&#xD;
      Diagnosis of dementia, age at initial dementia diagnosis, age at initial apathy diagnosis,&#xD;
      time since initial diagnosis of dementia and apathy will be obtained from medical records.&#xD;
      The type and daily dose of medication as well as the type and frequency of occupational,&#xD;
      physio- and psychosocial therapy will be drawn from medical records. The SMMSE (Severe Mini&#xD;
      Mental State Examination)score will determine severity of dementia and the AES (Apathy&#xD;
      Evaluation Scale )score the severity of apathy. Using the FAST (Functional Assessment&#xD;
      Staging) will assess the capacity of performing the activities of daily life.&#xD;
&#xD;
      Measurements will be conducted in a familiar environment and in the presence of a family&#xD;
      member or a member of staff to avoid any kind of stress and concern for the participant. The&#xD;
      subject will be informed of the procedure and their task before the sensors are attached.&#xD;
      Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the&#xD;
      subject views the image sequence on a PC monitor. EDA and HR will be recorded concurrently&#xD;
      using commercial software. Data analysis will involve both commercial and in-house software.&#xD;
      All data will be stored on a hard disk, in a compressed and encrypted format.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin conductance</measure>
    <time_frame>15 minutes</time_frame>
    <description>The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>15minutes</time_frame>
    <description>The heart rate measured in Hertz (HZ). The Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">133</enrollment>
  <condition>Emotions</condition>
  <condition>Dementia</condition>
  <condition>Apathy</condition>
  <arm_group>
    <arm_group_label>Patients with dementia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA will be measured using electrodes attached to the middle (D3) and ring finger (D4). Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand. A pulseoximeter is a non-invasive sensor, using tissue absorption of infrared light to determine blood-oxygen saturation (SaO2). EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin conductance and Heart rate measurement</intervention_name>
    <description>while observing selected photos the Skin conductance and heart rate will be measured.</description>
    <arm_group_label>Patients with dementia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  existing medical diagnosis of dementia, independent of the presence or absence of&#xD;
             neuropsychiatric symptoms.&#xD;
&#xD;
        We include nursing home residents with Informed Consent as documented by signature from the&#xD;
        German speaking part of Switzerland with moderate to severe dementia.&#xD;
&#xD;
        The presence or absence of apathy serves to assign participants into the appropriate&#xD;
        experiments group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse,&#xD;
&#xD;
               -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
                  psychological disorders&#xD;
&#xD;
               -  Previous enrolment into the current study,&#xD;
&#xD;
               -  Enrolment of the investigator, his/her family members, employees and other&#xD;
                  dependent persons,&#xD;
&#xD;
               -  Medically documented diagnosis of schizophrenia or bipolar disorder or the&#xD;
                  diagnosis of diminished intelligence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidrun Becker, Prof.DR.</last_name>
    <role>Study Chair</role>
    <affiliation>Zurich University of Applied Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silke Neumann, MSc</last_name>
    <phone>0041 58 934 49 76</phone>
    <email>neus@zhaw.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zurich University of applied Sciences</name>
      <address>
        <city>Winterthur</city>
        <state>Thurgau</state>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silke Neumann, MSc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 12, 2018</last_update_submitted>
  <last_update_submitted_qc>July 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zurich University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>Silke Neumann</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Aphathy</keyword>
  <keyword>Emotion</keyword>
  <keyword>Images</keyword>
  <keyword>Skin conductance</keyword>
  <keyword>Heart rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT03293537
org study id: Biomarker and Apathy
nct id: NCT03293537
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We want to determine if patients with dementia show any kind of emotion while they look at a
      defined selection of photos. These are photos taken from a international image-platform and
      mixed with photos (biographic) that show personal objects, personal events, etc.

      While the photos will be presented each a few seconds the skin conductance and the heart rate
      will be measured. We want to find out if there is any emotion measurable while showing the
      photos.
The lack of overt behaviour in individuals exhibiting dementia-associated apathy is not only
      stressful to family members and caregivers, it is also a major challenge for medical and
      nursing staff. Knowing whether apathy arises from an impaired function of the neural network
      of affect due to neurodegenerative processes accompanying dementia provides a neural
      explanation of this condition. Somatic indicators of affective responses (e.g., changes in
      skin conductance, or heart rate) are an effective means to uncover covert emotional responses
      in nursing home residents suffering from dementia associated apathy.

      The overall objective is to determine whether dementia associated apathy is the result of an
      impaired functioning of the neural macro-network of affect. We want to compare the
      quantitative change in physiological parameters for each image category between individuals
      of the two subgroups: 1. Individual with dementia only and 2.individuals with dementia and
      dementia-associated apathy.

      The primary objective is to uncover a covert emotional response using changes in skin
      conductance in patients with dementia and patients with dementia + dementia associated
      apathy.

      The secondary objective is to uncover a covert emotional response using changes in the heart
      rate in patients with dementia and patients with dementia + dementia associated apathy.

      Diagnosis of dementia, age at initial dementia diagnosis, age at initial apathy diagnosis,
      time since initial diagnosis of dementia and apathy will be obtained from medical records.
      The type and daily dose of medication as well as the type and frequency of occupational,
      physio- and psychosocial therapy will be drawn from medical records. The SMMSE (Severe Mini
      Mental State Examination)score will determine severity of dementia and the AES (Apathy
      Evaluation Scale )score the severity of apathy. Using the FAST (Functional Assessment
      Staging) will assess the capacity of performing the activities of daily life.

      Measurements will be conducted in a familiar environment and in the presence of a family
      member or a member of staff to avoid any kind of stress and concern for the participant. The
      subject will be informed of the procedure and their task before the sensors are attached.
      Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the
      subject views the image sequence on a PC monitor. EDA and HR will be recorded concurrently
      using commercial software. Data analysis will involve both commercial and in-house software.
      All data will be stored on a hard disk, in a compressed and encrypted format.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Skin conductance
time frame: 15 minutes
description: The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance
measure: Heart rate
time frame: 15minutes
description: The heart rate measured in Hertz (HZ). The Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand.
arm group label: Patients with dementia
arm group type: Experimental
description: The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA will be measured using electrodes attached to the middle (D3) and ring finger (D4). Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand. A pulseoximeter is a non-invasive sensor, using tissue absorption of infrared light to determine blood-oxygen saturation (SaO2). EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software.
intervention type: Diagnostic Test
intervention name: Skin conductance and Heart rate measurement
description: while observing selected photos the Skin conductance and heart rate will be measured.
arm group label: Patients with dementia
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Heidrun Becker, Prof.DR.
role: Study Chair
affiliation: Zurich University of Applied Sciences
last name: Silke Neumann, MSc
phone: 0041 58 934 49 76
email: neus@zhaw.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Zurich University of Applied Sciences
investigator full name: Silke Neumann
investigator title: MSc
mesh term: Dementia
sharing ipd: No