xml: <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/NCT05987540</url>
    </required_header>
    <id_info>
      <org_study_id>SNS-PD-004</org_study_id>
      <nct_id>NCT05987540</nct_id>
    </id_info>
    <brief_title>SHARPEN - Parkinson's Disease Dementia</brief_title>
    <acronym>SHARPEN</acronym>
    <official_title>Simple, Home-use Neurostimulation tReatment for Parkinson's Disease dEmeNtia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Scion NeuroStim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Scion NeuroStim</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this single arm study is to evaluate the feasibility and safety of treatments&#xD;
        with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's&#xD;
        disease dementia (PDD). A non-invasive device is a device that stays outside of the body and&#xD;
        is not implanted and does not penetrate the skin.&#xD;
  &#xD;
        Neuromodulation means that the device stimulates activity in the brain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Up to 12 participants will self-administer treatments twice daily in the home setting over a&#xD;
        period of 12 weeks. There are 4 study center visits, including an eligibility visit, as well&#xD;
        as multiple phone calls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of neuromodulation device use in PDD population</measure>
      <time_frame>12 weeks</time_frame>
      <description>The percentage of study participants reporting adverse events related to device use.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of neuromodulation device use in PDD population</measure>
      <time_frame>12 weeks</time_frame>
      <description>Retention rate or the percent of participants that complete the secondary endpoint at all study visits in the study protocol and treatment adherence rate during the 12-week treatment period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effects of device use on cognition in people with mild/moderate PDD</measure>
      <time_frame>12 weeks.</time_frame>
      <description>Change in the Montreal Cognitive Assessment (MoCA) between the baseline and end of treatment visit (Day 84) after 12 weeks of treatment. The MoCA is a cognitive assessment where scores range from zero to 30, with a higher score indicating a better cognitive function.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Parkinson Disease Dementia</condition>
    <arm_group>
      <arm_group_label>Investigational Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Investigational treatment mode (stimulation pattern)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-invasive brainstem stimulation</intervention_name>
      <description>Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.</description>
      <arm_group_label>Investigational Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with clinical diagnosis of probable PDD&#xD;
  &#xD;
            -  Positive response to levodopa and have been treated with levodopa-based therapies for&#xD;
               minimum of one years&#xD;
  &#xD;
            -  Participants must be willing and able to comply with all study requirements&#xD;
  &#xD;
            -  Participants must expect that the participant will be able to remain on a stable&#xD;
               regimen of concomitant therapies used for the management of PD and not to introduce&#xD;
               new medications used to treat PD (motor or non-motor symptoms) during the study&#xD;
  &#xD;
            -  Participant must have a study partner (defined as someone who sees the participant for&#xD;
               more than three hours a day, 5x per week) that is willing to consent and participate&#xD;
               in the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant anticipates being unable to attend all visits and complete all study&#xD;
               activities during the trial&#xD;
  &#xD;
            -  Women of child-bearing potential who are pregnant or plan to become pregnant during&#xD;
               the course of the trial&#xD;
  &#xD;
            -  Has experienced a heart attack, angina, or stroke within the past 12 months or&#xD;
               transient ischemic attack (TIA) within the past 6 months&#xD;
  &#xD;
            -  Are being treated with another neurostimulation device&#xD;
  &#xD;
            -  Demonstrate suicidality&#xD;
  &#xD;
            -  Have been previously diagnosed with either central vestibular dysfunction (lifetime)&#xD;
               or have experienced l peripheral vestibular dysfunction within the last 12 months.&#xD;
  &#xD;
            -  Have active ear infections, perforated tympanic membrane or labyrinthitis, as&#xD;
               identified by a general ear examination&#xD;
  &#xD;
            -  Have a recent history of frequent ear infections (≥ 1 per year over the past two&#xD;
               years)&#xD;
  &#xD;
            -  Have a cochlear implant, myringotomy tubes or hearing aids that cannot be&#xD;
               easily/reliably removed for treatment&#xD;
  &#xD;
            -  Have chronic tinnitus&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kara Richardson</last_name>
      <phone>984-884-1020</phone>
      <email>krichardson@scionneurostim.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>medical device</keyword>
    <keyword>Non-Invasive Brain Stimulation</keyword>
    <keyword>neuromodulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987540
  org study id: SNS-PD-004
  nct id: NCT05987540
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The purpose of this single arm study is to evaluate the feasibility and safety of treatments
        with a non-invasive neuromodulation device in adults diagnosed with mild/moderate Parkinson's
        disease dementia (PDD). A non-invasive device is a device that stays outside of the body and
        is not implanted and does not penetrate the skin.
  
        Neuromodulation means that the device stimulates activity in the brain.
  Up to 12 participants will self-administer treatments twice daily in the home setting over a
        period of 12 weeks. There are 4 study center visits, including an eligibility visit, as well
        as multiple phone calls.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety of neuromodulation device use in PDD population
  time frame: 12 weeks
  description: The percentage of study participants reporting adverse events related to device use.
  measure: Feasibility of neuromodulation device use in PDD population
  time frame: 12 weeks
  description: Retention rate or the percent of participants that complete the secondary endpoint at all study visits in the study protocol and treatment adherence rate during the 12-week treatment period.
  measure: Effects of device use on cognition in people with mild/moderate PDD
  time frame: 12 weeks.
  description: Change in the Montreal Cognitive Assessment (MoCA) between the baseline and end of treatment visit (Day 84) after 12 weeks of treatment. The MoCA is a cognitive assessment where scores range from zero to 30, with a higher score indicating a better cognitive function.
  arm group label: Investigational Treatment
  arm group type: Experimental
  description: Investigational treatment mode (stimulation pattern)
  intervention type: Device
  intervention name: Non-invasive brainstem stimulation
  description: Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device.
  arm group label: Investigational Treatment
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kara Richardson
  phone: 984-884-1020
  email: krichardson@scionneurostim.com
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Dementia
  sharing ipd: Undecided