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/NCT06028477</url>
    </required_header>
    <id_info>
      <org_study_id>71954</org_study_id>
      <nct_id>NCT06028477</nct_id>
    </id_info>
    <brief_title>Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study</brief_title>
    <official_title>Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</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 our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and&#xD;
        its effects on Parkinson's symptoms. vCR will be administered with a device called the&#xD;
        Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the&#xD;
        most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be&#xD;
        followed for 14 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to test the efficacy of vibrotactile coordinated reset&#xD;
        stimulation on human subject participants with Parkinson's disease and inform the&#xD;
        investigators on whether unilateral stimulation could be as effective as bilateral&#xD;
        stimulation at producing clinically significant improvements in symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 29, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in MDS-UPDRS Part III Scale Score</measure>
      <time_frame>Baseline and month 6</time_frame>
      <description>Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Active stimulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Stimulation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stanford Glove</intervention_name>
      <description>The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.</description>
      <arm_group_label>Active stimulation</arm_group_label>
      <arm_group_label>Sham Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - 1. Ages 18 or older 2. Diagnosed with idiopathic Parkinson's Disease 3. Fluent in English&#xD;
          4. Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before&#xD;
          study consent or at Screening Visit.&#xD;
  &#xD;
          5. Demonstrates understanding of the study requirements and is able and willing to sign the&#xD;
          informed consent form and complete study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1. Participation in another drug, device, or biologics trial concurrently or within the&#xD;
          preceding 30 days. Any other trial participation should be approved by the Principal&#xD;
          Investigators.&#xD;
  &#xD;
          2. Pregnancy, breast-feeding or wanting to become pregnant 3. Physical limitations&#xD;
          unrelated to PD that would affect motor ratings 4. Has implantation of a medical device 5.&#xD;
          Sensory abnormalities of the fingertips&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>92 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vivek P Buch, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica Yankulova</last_name>
      <phone>650-474-9547</phone>
      <email>jessky@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ellyn Daly</last_name>
      <email>ellynd@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Vivek P. Buch</investigator_full_name>
      <investigator_title>Assistant Professor of Neurosurgery</investigator_title>
    </responsible_party>
    <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>
  
  
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/NCT06028477
  org study id: 71954
  nct id: NCT06028477
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and
        its effects on Parkinson's symptoms. vCR will be administered with a device called the
        Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the
        most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be
        followed for 14 months.
  The purpose of this study is to test the efficacy of vibrotactile coordinated reset
        stimulation on human subject participants with Parkinson's disease and inform the
        investigators on whether unilateral stimulation could be as effective as bilateral
        stimulation at producing clinically significant improvements in symptoms.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
  measure: Change in MDS-UPDRS Part III Scale Score
  time frame: Baseline and month 6
  description: Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.
  arm group label: Active stimulation
  arm group type: Active Comparator
  description: Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
  arm group label: Sham Stimulation
  arm group type: Sham Comparator
  description: Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
  intervention type: Device
  intervention name: Stanford Glove
  description: The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.
  arm group label: Active stimulation
  arm group label: Sham Stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 92 Years
  healthy volunteers: No
  last name: Vivek P Buch, MD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Jessica Yankulova
  phone: 650-474-9547
  email: jessky@stanford.edu
  last name: Ellyn Daly
  email: ellynd@stanford.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Vivek P. Buch
  investigator title: Assistant Professor of Neurosurgery
  mesh term: Parkinson Disease
  sharing ipd: No