<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/NCT03247387</url>
  </required_header>
  <id_info>
    <org_study_id>H-35364</org_study_id>
    <nct_id>NCT03247387</nct_id>
  </id_info>
  <brief_title>eOnOff - D1 Extension</brief_title>
  <official_title>Evaluation of the eON-OFF Mobile Application and Four Actigraphy Devices in Subjects With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</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>
      Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while&#xD;
      wearable devices can offer immensely more information that can improve the understanding of&#xD;
      this disease. With recent advancements in technology, investigators are now able to use&#xD;
      watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of&#xD;
      the doctor's office. The present study is designed to evaluate the usability, applicability,&#xD;
      and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC&#xD;
      actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's&#xD;
      Disease. There is no placebo/control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will be comprised of at least four sessions in the Spivack Center (Rm.&#xD;
      X-140) on separate days (not counting recruitment, screening, or consent activities), each&#xD;
      lasting approximately 1-2 hours. Subjects will commence a 1-week testing period during which&#xD;
      they will wear the 3 actigraphy devices in their normal schedule and daily environment. On&#xD;
      Days 2, 3, 4, and 5, subjects will use the eON-OFF motor diary application to select their&#xD;
      current Parkinson state (e.g. &quot;on&quot;, &quot;off&quot;). ON and OFF states are subjective measures&#xD;
      identified by subjects, and are commonly used words in Parkinson's Disease treatment and&#xD;
      research to describe symptom states. Symptom severity is directly linked to medication&#xD;
      effectiveness. &quot;On&quot; is when the medication is working and symptoms are not severe or&#xD;
      troublesome. &quot;Off&quot; is when medication has worn off, and symptom severity increases. Subjects&#xD;
      will also use the eON-OFF motor diary application to verbally record symptomology every 30&#xD;
      minutes while awake. Subjects will complete paper VA Patient Motor Diaries to record ON and&#xD;
      OFF states on Day 2, Day 3, and Day 4. Subjects will then complete the outlined set of&#xD;
      activities during Phase I in a second phase to take place approximately one month later. All&#xD;
      questionnaires, training and interviews will be administered one-on-one by a trained research&#xD;
      assistant. All UPDRS' will be administered by a clinician. Ideally, subjects will be&#xD;
      administered the study activities on the days listed above, but they are allowed a&#xD;
      flexibility of +/- 4 days for scheduling appointments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of eON-OFF mobile application (&quot;eON-OFF app&quot;) in PD subjects.</measure>
    <time_frame>2 week long periods spaced a month apart</time_frame>
    <description>Subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. &quot;on&quot;, &quot;off&quot;). Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Equivalence testing of the eON-OFF app on provisioned devices against established paper-based clinical assessment.</measure>
    <time_frame>2 week long periods spaced a month apart</time_frame>
    <description>Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states. ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the usability and applicability of 3 wearable sensor systems in assessing clinical measures of PD.</measure>
    <time_frame>2 week long periods spaced a month apart</time_frame>
    <description>Subjects will undergo two, 1-week testing periods during which they will wear the 3 actigraphy devices in their normal schedule and daily environment.</description>
  </secondary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Parkinson Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MC10 BioStampRC</intervention_name>
    <description>Subjects will fill out electronic diaries on a provisioned iPhone to capture &quot;On&quot; versus &quot;Off&quot; time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>APDM actigraphy device</intervention_name>
    <description>Subjects will fill out electronic diaries on a provisioned iPhone to capture &quot;On&quot; versus &quot;Off&quot; time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GENEActiv watch</intervention_name>
    <description>Subjects will fill out electronic diaries on a provisioned iPhone to capture &quot;On&quot; versus &quot;Off&quot; time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals diagnosed with Parkinson's disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-reported clinical diagnosis of Parkinson's disease consistent with the United&#xD;
             Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.&#xD;
&#xD;
          -  Self-reported ability to recognize their &quot;wearing off&quot; symptoms and confirmation that&#xD;
             they usually improve after their next dose of Parkinson's disease medication.&#xD;
&#xD;
          -  Parkinson's disease Hoehn &amp; Yahr Stage less than or equal to III (assessed while the&#xD;
             patient is &quot;ON&quot;).&#xD;
&#xD;
          -  Currently responding to L-Dopa therapy. On a stable dose of L-Dopa (or L-Dopa&#xD;
             equivalent) of at least 300 mg total daily dose for at least 28 days prior to Day 1,&#xD;
             in conjunction with a dopa decarboxylase inhibitor (e.g., L-Dopa/carbidopa or&#xD;
             L-Dopa/benserazide) divided in at least 3 divided doses per day.&#xD;
&#xD;
          -  45-75 years old&#xD;
&#xD;
          -  Able to understand and cooperate with study procedures and give informed consent.&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight of greater than or&#xD;
             equal to 45kg.&#xD;
&#xD;
          -  Native English speaker or demonstrated fluency in English.&#xD;
&#xD;
          -  Normal or corrected-to-normal vision&#xD;
&#xD;
          -  A score of greater than or equal to 26 on the Mini Mental State Examination (MMSE).&#xD;
&#xD;
          -  A score of 49 on the Green Form of the WRAT-4 Word Reading Subtest (equivalent to 8th&#xD;
             grade reading level)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with an investigational drug within 30 days of Day 1 of study activities.&#xD;
&#xD;
          -  Diagnosis of moderate to severe alcohol use disorder within 6 months of the screening&#xD;
             as disclosed by the subject&#xD;
&#xD;
          -  Employees, student, or advisee of the Principal Investigator&#xD;
&#xD;
          -  History of head injury with clinically significant sequelae (e.g. loss of&#xD;
             consciousness for greater than 15 minutes).&#xD;
&#xD;
          -  DSM-V diagnosis of current, or history of, neurological disease (except for&#xD;
             Parkinson's disease), Schizophrenia Spectrum or Other Psychotic disorders, or Bipolar&#xD;
             and Related Disorders as disclosed by the subject.&#xD;
&#xD;
          -  Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical&#xD;
             devices, including deep brain stimulation devices.&#xD;
&#xD;
          -  Women of childbearing age will be required to undergo a pregnancy test to rule out a&#xD;
             possible pregnancy.&#xD;
&#xD;
          -  Allergy to adhesives or silicone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin C Thomas, PhD MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>BU Anatomy and Neurology Dept, Evans Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evans Biomedical Research Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Kevin C.Thomas</investigator_full_name>
    <investigator_title>Assistant Professor, Anatomy &amp; Neurobiology</investigator_title>
  </responsible_party>
  <keyword>Wearable device</keyword>
  <keyword>Patient monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03247387
org study id: H-35364
nct id: NCT03247387
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while
      wearable devices can offer immensely more information that can improve the understanding of
      this disease. With recent advancements in technology, investigators are now able to use
      watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of
      the doctor's office. The present study is designed to evaluate the usability, applicability,
      and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC
      actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's
      Disease. There is no placebo/control group.
The proposed study will be comprised of at least four sessions in the Spivack Center (Rm.
      X-140) on separate days (not counting recruitment, screening, or consent activities), each
      lasting approximately 1-2 hours. Subjects will commence a 1-week testing period during which
      they will wear the 3 actigraphy devices in their normal schedule and daily environment. On
      Days 2, 3, 4, and 5, subjects will use the eON-OFF motor diary application to select their
      current Parkinson state (e.g. "on", "off"). ON and OFF states are subjective measures
      identified by subjects, and are commonly used words in Parkinson's Disease treatment and
      research to describe symptom states. Symptom severity is directly linked to medication
      effectiveness. "On" is when the medication is working and symptoms are not severe or
      troublesome. "Off" is when medication has worn off, and symptom severity increases. Subjects
      will also use the eON-OFF motor diary application to verbally record symptomology every 30
      minutes while awake. Subjects will complete paper VA Patient Motor Diaries to record ON and
      OFF states on Day 2, Day 3, and Day 4. Subjects will then complete the outlined set of
      activities during Phase I in a second phase to take place approximately one month later. All
      questionnaires, training and interviews will be administered one-on-one by a trained research
      assistant. All UPDRS' will be administered by a clinician. Ideally, subjects will be
      administered the study activities on the days listed above, but they are allowed a
      flexibility of +/- 4 days for scheduling appointments.
observational model: Case-Only
time perspective: Prospective
measure: Assessment of eON-OFF mobile application ("eON-OFF app") in PD subjects.
time frame: 2 week long periods spaced a month apart
description: Subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. "on", "off"). Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake.
measure: Equivalence testing of the eON-OFF app on provisioned devices against established paper-based clinical assessment.
time frame: 2 week long periods spaced a month apart
description: Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states. ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states.
measure: Evaluation of the usability and applicability of 3 wearable sensor systems in assessing clinical measures of PD.
time frame: 2 week long periods spaced a month apart
description: Subjects will undergo two, 1-week testing periods during which they will wear the 3 actigraphy devices in their normal schedule and daily environment.
intervention type: Device
intervention name: MC10 BioStampRC
description: Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.
intervention type: Device
intervention name: APDM actigraphy device
description: Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.
intervention type: Device
intervention name: GENEActiv watch
description: Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kevin C Thomas, PhD MBA
role: Principal Investigator
affiliation: BU Anatomy and Neurology Dept, Evans Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Kevin C.Thomas
investigator title: Assistant Professor, Anatomy & Neurobiology
mesh term: Parkinson Disease
sharing ipd: No