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/NCT06029686</url>
    </required_header>
    <id_info>
      <org_study_id>71725</org_study_id>
      <nct_id>NCT06029686</nct_id>
    </id_info>
    <brief_title>Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population</brief_title>
    <official_title>Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population</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>No</is_fda_regulated_device>
    </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 of a more variable population. vCR will be administered&#xD;
        with a device called the Stanford Glove. vCR is expected to provide patients with a&#xD;
        non-invasive alternative to the most widely used treatments such as Levodopa and or deep&#xD;
        brain stimulation. Patients will be followed for two years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score</measure>
      <time_frame>6 months</time_frame>
      <description>Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.&#xD;
  Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment&#xD;
  Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be asked to stimulate using a non invasive vibrotactile device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stanford Glove</intervention_name>
      <description>The vibrotactile device sends weak non-painful pattern type vibratory stimulus to the fingertips and is non-invasive. Some patient may experience dyskinesia which can me medicated with a decrease in Parkinson's medication</description>
      <arm_group_label>Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age at the time of enrollment: 35 - 92 years&#xD;
  &#xD;
            2. Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to&#xD;
  &#xD;
            3. Fluent in English&#xD;
  &#xD;
            4. Comfortable with technology; can use a computer, check email, and access the internet;&#xD;
               can initiate and engage in a virtual meeting for training and monitoring purposes.&#xD;
  &#xD;
            5. Feels comfortable going off PD related medication during in person study visits&#xD;
  &#xD;
            6. Lives in the United States&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing&#xD;
               psychosis, or suicidal tendencies&#xD;
  &#xD;
            2. Any current drug or alcohol abuse.&#xD;
  &#xD;
            3. 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;
            4. Pregnancy, breast-feeding or wanting to become pregnant&#xD;
  &#xD;
            5. Craniotomy&#xD;
  &#xD;
            6. Brain surgery&#xD;
  &#xD;
            7. Patient is unable to communicate properly with staff (i.e., severe speech problems)&#xD;
  &#xD;
            8. Excessive drooling&#xD;
  &#xD;
            9. Patient is taking a medication that may cause significant withdrawal effects&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jessica K Yankulova, MA</last_name>
      <phone>6504749547</phone>
      <email>jessky@stanford.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Peter Tass, MD, PhD</investigator_full_name>
      <investigator_title>Principal Investigator</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>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/NCT06029686
  org study id: 71725
  nct id: NCT06029686
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and
        its effects on Parkinson's symptoms of a more variable population. 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 two years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score
  time frame: 6 months
  description: Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.
  Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment
  Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.
  arm group label: Stimulation
  arm group type: Experimental
  description: Patients will be asked to stimulate using a non invasive vibrotactile device.
  intervention type: Device
  intervention name: Stanford Glove
  description: The vibrotactile device sends weak non-painful pattern type vibratory stimulus to the fingertips and is non-invasive. Some patient may experience dyskinesia which can me medicated with a decrease in Parkinson's medication
  arm group label: Stimulation
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Jessica K Yankulova, MA
  phone: 6504749547
  email: jessky@stanford.edu
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Peter Tass, MD, PhD
  investigator title: Principal Investigator
  mesh term: Parkinson Disease
  sharing ipd: Undecided