<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/NCT03799614</url>
  </required_header>
  <id_info>
    <org_study_id>HM20012404</org_study_id>
    <nct_id>NCT03799614</nct_id>
  </id_info>
  <brief_title>Vibration Impact on Parkinson's Tremor</brief_title>
  <official_title>Vibration Impact on Parkinson's Tremor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to test the safety, tolerability and efficacy of&#xD;
      vibration (delivered by an experimental device called RMBand that is worn on the subject's&#xD;
      arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This&#xD;
      RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in&#xD;
      persons with Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participation will be completed in one visit at VCU Parkinson's and Movement Disorders&#xD;
      Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale&#xD;
      (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will&#xD;
      be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part&#xD;
      III will be repeated both during and after the therapy. Participants will be asked to provide&#xD;
      feedback about the device, the therapy session and how they are feeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Actual">November 27, 2019</completion_date>
  <primary_completion_date type="Actual">November 27, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)</measure>
    <time_frame>This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.</time_frame>
    <description>The &quot;Movement Disorder Society Unified Parkinson Disease Rating Scale&quot; (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Rating for Tremor</measure>
    <time_frame>Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .</time_frame>
    <description>Clinical Rating Scale for Tremor (Fahn, Tolosa, &amp; Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor.&#xD;
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Measurement of Tremor Frequency (Hz)</measure>
    <time_frame>Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.</time_frame>
    <description>This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Measurement of Tremor Amplitude (mm).</measure>
    <time_frame>Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.</time_frame>
    <description>This is a device that will objectively measure tremor amplitude pre, during, and post treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Lower dose vibration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RMBand lower dose vibration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher dose vibration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RMBand higher dose vibration</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RMBand lower dose</intervention_name>
    <description>Light-weight portable device that delivers low dose vibration to the arm</description>
    <arm_group_label>Lower dose vibration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RMBand higher dose</intervention_name>
    <description>Light-weight portable device that delivers higher dose vibration to the arm</description>
    <arm_group_label>Higher dose vibration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease (PD) as diagnosed by a movement disorder specialist&#xD;
&#xD;
          -  Tremor caused by their Parkinson's disease&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known diagnosis of Parkinson Plus Syndrome&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Other known non-PD cause of tremor&#xD;
&#xD;
          -  Other known non-PD cause of limb dysfunction&#xD;
&#xD;
          -  Presence of implantable cardiac device, severe neuropathy or sensory loss that would&#xD;
             prevent perception of vibration stimulus&#xD;
&#xD;
          -  Non-English speaker&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Pretzer-Aboff, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>November 19, 2020</results_first_submitted>
  <results_first_submitted_qc>November 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2020</results_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03799614/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low Dose Vibration</title>
          <description>RMBand lower dose vibration&#xD;
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm</description>
        </group>
        <group group_id="P2">
          <title>High Dose Vibration</title>
          <description>RMBand higher dose vibration&#xD;
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lower Dose Vibration</title>
          <description>RMBand lower dose vibration&#xD;
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm</description>
        </group>
        <group group_id="B2">
          <title>Higher Dose Vibration</title>
          <description>RMBand higher dose vibration&#xD;
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" spread="6.7"/>
                    <measurement group_id="B2" value="67.6" spread="8.4"/>
                    <measurement group_id="B3" value="67.4" spread="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clinical Rating Scale for Tremor, total score</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.13" spread="10.69"/>
                    <measurement group_id="B2" value="18.07" spread="5.22"/>
                    <measurement group_id="B3" value="19.6" spread="8.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MDS UPDRS II - IV total</title>
          <description>Movement Disorder Society Unified Parkinson Rating Scale, (MDS UPDRS, score for parts II - !V.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.26" spread="16.41"/>
                    <measurement group_id="B2" value="38.47" spread="14.08"/>
                    <measurement group_id="B3" value="41.37" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)</title>
        <description>The &quot;Movement Disorder Society Unified Parkinson Disease Rating Scale&quot; (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.</description>
        <time_frame>This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vibration</title>
            <description>RMBand low dose vibration&#xD;
RMBand: Light-weight portable device that delivers low dose vibration to the arm</description>
          </group>
          <group group_id="O2">
            <title>Higher Dose Vibration</title>
            <description>RMBand high dose vibration&#xD;
RMBand: Light-weight portable device that delivers higher dose vibration to the arm</description>
          </group>
        </group_list>
        <measure>
          <title>Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)</title>
          <description>The &quot;Movement Disorder Society Unified Parkinson Disease Rating Scale&quot; (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.67" spread="12.88"/>
                    <measurement group_id="O2" value="27.4" spread="11.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During vibration treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.67" spread="14.31"/>
                    <measurement group_id="O2" value="27.33" spread="11.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post vibration treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.67" spread="13.67"/>
                    <measurement group_id="O2" value="28.6" spread="10.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Rating for Tremor</title>
        <description>Clinical Rating Scale for Tremor (Fahn, Tolosa, &amp; Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor.&#xD;
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.</description>
        <time_frame>Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lower Dose Vibration</title>
            <description>RMBand lower dose vibration&#xD;
RMBand lower dose: Light-weight portable device that delivers low dose vibration to the arm</description>
          </group>
          <group group_id="O2">
            <title>Higher Dose Vibration</title>
            <description>RMBand higher dose vibration&#xD;
RMBand higher dose: Light-weight portable device that delivers higher dose vibration to the arm</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Rating for Tremor</title>
          <description>Clinical Rating Scale for Tremor (Fahn, Tolosa, &amp; Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor.&#xD;
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.47" spread="7.94"/>
                    <measurement group_id="O2" value="13.87" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.87" spread="8.55"/>
                    <measurement group_id="O2" value="13.20" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.53" spread="7.98"/>
                    <measurement group_id="O2" value="14.13" spread="5.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Measurement of Tremor Frequency (Hz)</title>
        <description>This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.</description>
        <time_frame>Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vibration</title>
            <description>RMBand low dose vibration&#xD;
RMBand: Light-weight portable device that delivers low dose vibration to the arm</description>
          </group>
          <group group_id="O2">
            <title>Higher Dose Vibration</title>
            <description>RMBand high dose vibration&#xD;
RMBand: Light-weight portable device that delivers higher dose vibration to the arm</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Measurement of Tremor Frequency (Hz)</title>
          <description>This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.</description>
          <units>hertz</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="1.57"/>
                    <measurement group_id="O2" value="4.51" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.79" spread="1.13"/>
                    <measurement group_id="O2" value="3.99" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.87"/>
                    <measurement group_id="O2" value="4.64" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Measurement of Tremor Amplitude (mm).</title>
        <description>This is a device that will objectively measure tremor amplitude pre, during, and post treatment.</description>
        <time_frame>Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose Vibration Amplitude</title>
            <description>RMBand low dose vibration&#xD;
RMBand: Light-weight portable device that delivers low dose vibration to the arm,reported in mm.</description>
          </group>
          <group group_id="O2">
            <title>Higher Dose Vibration</title>
            <description>RMBand high dose vibration&#xD;
RMBand: Light-weight portable device that delivers higher dose vibration to the arm</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Measurement of Tremor Amplitude (mm).</title>
          <description>This is a device that will objectively measure tremor amplitude pre, during, and post treatment.</description>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.82"/>
                    <measurement group_id="O2" value="0.43" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.72"/>
                    <measurement group_id="O2" value="0.44" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.75"/>
                    <measurement group_id="O2" value="0.52" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>two hours, during time of study activities</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lower Dose Vibration</title>
          <description>RMBand lower dose vibration&#xD;
RMBand lower dose: Light-weight portable device that delivers low dose vibration (frequency of 80 Hz) to the arm</description>
        </group>
        <group group_id="E2">
          <title>Higher Dose Vibration</title>
          <description>RMBand higher dose vibration&#xD;
RMBand higher dose: Light-weight portable device that delivers higher dose (frequency of 160 Hz) vibration to the arm</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>muscle tightness</sub_title>
                <description>tightness in muscles in right shoulder and neck</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ingrid Pretzer-Aboff</name_or_title>
      <organization>Virginia Commonwealth University</organization>
      <phone>804-828-3340</phone>
      <email>iaboff@vcu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03799614
org study id: HM20012404
nct id: NCT03799614
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary purpose of this study is to test the safety, tolerability and efficacy of
      vibration (delivered by an experimental device called RMBand that is worn on the subject's
      arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This
      RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in
      persons with Parkinson's disease (PD).
Participation will be completed in one visit at VCU Parkinson's and Movement Disorders
      Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale
      (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will
      be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part
      III will be repeated both during and after the therapy. Participants will be asked to provide
      feedback about the device, the therapy session and how they are feeling.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
time frame: This rating scale will be used at baseline, 5 minutes after vibration starts, and 5 minutes after vibration is turned off.
description: The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS) Part III, only, will be used at baseline, and repeated during vibration and post vibration data collection times. It is a validated scale administered by a clinician, contains 34 items to score between 0 (normal) and 4 (severe). The score range is 0 - 136. It takes ~ 5 minutes to complete. Lower scores are better. This outcome measure will be used to report a change in PD motor symptoms over time.
measure: Clinical Rating for Tremor
time frame: Data collection times were baseline, 5 minutes after vibration start (vibration duration was 20 minutes), 5 minutes after vibration was stopped. .
description: Clinical Rating Scale for Tremor (Fahn, Tolosa, & Marin) assesses severity of tremor symptoms. This scale takes 10-minutes, Items 1 - 14 will be used to report average changes in tremor.
Items are rated on a scale of 0=normal to 4=severely abnormal, total summative score range for items 1- 14 points is 0 - 56. Lower scores are better. Total time to complete the Scale for Tremor assessment is 10 minutes.
measure: Objective Measurement of Tremor Frequency (Hz)
time frame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
description: This is a device that will objectively measure tremors frequency and amplitude pre, during, and post treatment.
measure: Objective Measurement of Tremor Amplitude (mm).
time frame: Five minutes before vibration is turned on, throughout vibration treatment, and approximately five minutes post treatment.
description: This is a device that will objectively measure tremor amplitude pre, during, and post treatment.
arm group label: Lower dose vibration
arm group type: Experimental
description: RMBand lower dose vibration
arm group label: Higher dose vibration
arm group type: Experimental
description: RMBand higher dose vibration
intervention type: Device
intervention name: RMBand lower dose
description: Light-weight portable device that delivers low dose vibration to the arm
arm group label: Lower dose vibration
intervention type: Device
intervention name: RMBand higher dose
description: Light-weight portable device that delivers higher dose vibration to the arm
arm group label: Higher dose vibration
criteria: 
gender: All
minimum age: 21 Years
maximum age: 95 Years
healthy volunteers: No
last name: Ingrid Pretzer-Aboff, PhD, RN
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 