<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/NCT03795168</url>
  </required_header>
  <id_info>
    <org_study_id>OLith10301</org_study_id>
    <nct_id>NCT03795168</nct_id>
  </id_info>
  <brief_title>Transcranial Vibrating System for Improving Vestibular Physical Therapy</brief_title>
  <official_title>Transcranial Vibrating System for Improving Outcomes of Vestibular Physical Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otolith Labs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otolith Labs</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study aims to determine whether low-frequency transcranial vibrations can act&#xD;
      as a possible treatment for the dizziness and nausea often associated with vestibular&#xD;
      physical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effectiveness of a Transcranial Vibration&#xD;
      System (TCVS) at reducing the increased nausea and discomfort sometimes associated with&#xD;
      vestibular physical therapy. The TCVS is a small device attached to an elastic band. It is&#xD;
      worn around the head and produces vibrations. There is no implant or surgical procedure. The&#xD;
      FDA has made a pre-determination that this is a low-risk device (a &quot;Class 2 device&quot; in FDA&#xD;
      terminology).&#xD;
&#xD;
      The TCVS has previously been tested in healthy volunteers and has been found to safely and&#xD;
      effectively decrease dizziness and nausea associated with vestibular discomfort. This study&#xD;
      will expand that research to vestibular disorder patients who are undergoing physical&#xD;
      therapy. The study compares the outcomes to not wearing a device, or to a control&#xD;
      (inneffective) device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study center closed down&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>Arm 1: Participants undergoing vestibular physical therapy (PT) will perform PT exercises with or without wearing the transcranial vibrating system (TCVS). Following the end of their PT exercises (30 minutes or less if the participant was too dizzy to finish), participants will evaluate dizziness using a dizziness symptom scale (DSS) and PT exercise duration will be recorded. A force plate system assessment will also be performed with or without wearing the TCVS during the first and last PT visit to evaluate participant's balance.&#xD;
Arm 2: Participants will undergo the identical protocol as arm 1 with the exception that participants will wear the TCVS at optimal vibration frequency or the TCVS at irrelevant vibration frequency (sham).&#xD;
To determine TCVD's effect on dizziness and balance, the outcomes measured in both arms (1. DSS, 2. duration of PT exercise, 3. balance) will be compared statistically between:&#xD;
TCVD versus no device&#xD;
TCVD optimal frequency versus TCVD sham</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Arm 1: their will be no masking as the participants will either wear the transcranial vibrating system (TCVS) or not.&#xD;
Arm 2: the investigators will be provided 2 TCVS by the sponsor, labeled A or B, which will be randomly assigned to participants by the sponsor. One TCVS will be set at the optimal vibration frequency and the other TCVS will be set at an irrelevant vibration frequency (sham). The investigators and the participants will not know which TCVS is optimal or sham, thus the arm 2 will be double blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in duration of the vestibular physical therapy exercise session</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The participants will perform vestibular physical therapy exercises for 30 minutes unless their dizziness symptoms prevend them to finish. The change in vestibular physical therapy exercises they can perform will be recorded by the investigator. This value will be recorded immediately after they finish their physical therapy exercises.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dizziness index</measure>
    <time_frame>Questionaire immediately after the end of physical therapy exercise</time_frame>
    <description>The dizziness index will be evaluated with the Dizziness Symptom Scale (DSS) with a scale from 1 (no dizziness) to 10 (strong dizziness). The change of DSS will be evaluated between participants wearing:&#xD;
the transcranial vibrating system (TCVS)&#xD;
no TCVS&#xD;
the TCVS sham</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in balance</measure>
    <time_frame>During first and last vestibular physical therapy visit; expected duration maximum 10 minutes</time_frame>
    <description>Participant's balance will be evaluated with a force plate platform (Bertec Device). Participants will be placed on the plate 1. eyes open, 2. eyes closed, 3. eyes open while standing on a foam pad, 4. eyes closed while standing on a foam pad. Each of the 4 conditions will involve the participant standing barefoot on a force plate platform for 10 seconds. The change in participant's balance (X&amp;Y direction) will be assessed by recording values of the Bertec device in two conditions: first with participants not wearing the TCVS and second with participants wearing the TCVS at optimal vibration frequency or wearing the TCVS sham. Clinical parameters obtained from the Bertec system will be recorded, including &quot;falls&quot; and will be compared between conditions to evaluate participant's change in balance. Participants will always be held safe with a harness secured to a mount point in the ceiling.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Vertigo</condition>
  <condition>Dizziness</condition>
  <condition>Nausea</condition>
  <condition>Balance</condition>
  <arm_group>
    <arm_group_label>Transcranial vibrating system effect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. During the first 2 weeks (4 visits), 20 participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) and the other 20 participants without. The following 2 consecutive weeks (4 visits), participants will perform their PT exercises wearing the TCVS if they weren't previously, or won't wear the device during their PT exercises if they were previously.&#xD;
Outcomes measured:&#xD;
at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise&#xD;
at the first and last visit: force plate system assessment (balance)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vs transcranial vibrating system sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>40 participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. Participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) at optimal vibrating frequency or wearing the TCVS at irrelevant vibrating frequency (sham). The TCVS and TCVS sham will be labeled A or B by the sponsor. The investigators and participants will not know which TCVS is optimal or sham. The sponsor will randomly assign participants TCVS A or B.&#xD;
Outcomes measured:&#xD;
at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise&#xD;
at the first and last visit: force plate system assessment (balance)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial vibrating system</intervention_name>
    <description>The transcranial vibrating system (TCVS) will be worn by participants performing vestibular physical therapy (PT) exercises. The TCVS vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises. The TCVS will be set at an optimal vibration frequency as determined in a previous study.</description>
    <arm_group_label>Transcranial vibrating system effect</arm_group_label>
    <arm_group_label>Vs transcranial vibrating system sham</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial vibrating system sham</intervention_name>
    <description>A transcranial vibrating system (TCVS) sham set at an irrelevant vibrating frequency will be worn by participants performing vestibular physical therapy (PT) exercises in arm 2. The TCVS sham vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS sham will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises.</description>
    <arm_group_label>Vs transcranial vibrating system sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  reluctant or unable to perform a full session of vestibular physical therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of head injury within the last six months or currently suffering the effects&#xD;
             of a head injury (i.e. concussion or traumatic brain injury)&#xD;
&#xD;
          -  Presence of severe aphasia.&#xD;
&#xD;
          -  History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major&#xD;
             depression, schizophrenia).&#xD;
&#xD;
          -  Documented neurodegenerative disorders.&#xD;
&#xD;
          -  Pregnancy Female candidates will be asked to take a pregnancy test first and will have&#xD;
             to make a informed decision to participate based on the results of the pregnancy test.&#xD;
&#xD;
          -  History of Cerebrovascular disorders.&#xD;
&#xD;
          -  History of ear operation other than myringotomy and tube placement in the past.&#xD;
&#xD;
          -  Systemic disorders to include chronic renal failure, cirrhosis of the liver,&#xD;
             autoimmune disease, heart disease, lung disease, or severe arthritis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Didier Depireux, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Otolith Labs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fyzical - Dizziness and Fall Prevention - Shady Grove</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FYZICAL Therapy &amp; Balance Center of Rockville</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vestibular physical therapy</keyword>
  <keyword>Positional vertigo</keyword>
  <keyword>Ménière's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Dizziness</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/NCT03795168
org study id: OLith10301
nct id: NCT03795168
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This research study aims to determine whether low-frequency transcranial vibrations can act
      as a possible treatment for the dizziness and nausea often associated with vestibular
      physical therapy.
The purpose of this study is to determine the effectiveness of a Transcranial Vibration
      System (TCVS) at reducing the increased nausea and discomfort sometimes associated with
      vestibular physical therapy. The TCVS is a small device attached to an elastic band. It is
      worn around the head and produces vibrations. There is no implant or surgical procedure. The
      FDA has made a pre-determination that this is a low-risk device (a "Class 2 device" in FDA
      terminology).

      The TCVS has previously been tested in healthy volunteers and has been found to safely and
      effectively decrease dizziness and nausea associated with vestibular discomfort. This study
      will expand that research to vestibular disorder patients who are undergoing physical
      therapy. The study compares the outcomes to not wearing a device, or to a control
      (inneffective) device.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Arm 1: Participants undergoing vestibular physical therapy (PT) will perform PT exercises with or without wearing the transcranial vibrating system (TCVS). Following the end of their PT exercises (30 minutes or less if the participant was too dizzy to finish), participants will evaluate dizziness using a dizziness symptom scale (DSS) and PT exercise duration will be recorded. A force plate system assessment will also be performed with or without wearing the TCVS during the first and last PT visit to evaluate participant's balance.
Arm 2: Participants will undergo the identical protocol as arm 1 with the exception that participants will wear the TCVS at optimal vibration frequency or the TCVS at irrelevant vibration frequency (sham).
To determine TCVD's effect on dizziness and balance, the outcomes measured in both arms (1. DSS, 2. duration of PT exercise, 3. balance) will be compared statistically between:
TCVD versus no device
TCVD optimal frequency versus TCVD sham
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Arm 1: their will be no masking as the participants will either wear the transcranial vibrating system (TCVS) or not.
Arm 2: the investigators will be provided 2 TCVS by the sponsor, labeled A or B, which will be randomly assigned to participants by the sponsor. One TCVS will be set at the optimal vibration frequency and the other TCVS will be set at an irrelevant vibration frequency (sham). The investigators and the participants will not know which TCVS is optimal or sham, thus the arm 2 will be double blinded.
measure: Change in duration of the vestibular physical therapy exercise session
time frame: up to 30 minutes
description: The participants will perform vestibular physical therapy exercises for 30 minutes unless their dizziness symptoms prevend them to finish. The change in vestibular physical therapy exercises they can perform will be recorded by the investigator. This value will be recorded immediately after they finish their physical therapy exercises.
measure: Change in dizziness index
time frame: Questionaire immediately after the end of physical therapy exercise
description: The dizziness index will be evaluated with the Dizziness Symptom Scale (DSS) with a scale from 1 (no dizziness) to 10 (strong dizziness). The change of DSS will be evaluated between participants wearing:
the transcranial vibrating system (TCVS)
no TCVS
the TCVS sham
measure: Change in balance
time frame: During first and last vestibular physical therapy visit; expected duration maximum 10 minutes
description: Participant's balance will be evaluated with a force plate platform (Bertec Device). Participants will be placed on the plate 1. eyes open, 2. eyes closed, 3. eyes open while standing on a foam pad, 4. eyes closed while standing on a foam pad. Each of the 4 conditions will involve the participant standing barefoot on a force plate platform for 10 seconds. The change in participant's balance (X&Y direction) will be assessed by recording values of the Bertec device in two conditions: first with participants not wearing the TCVS and second with participants wearing the TCVS at optimal vibration frequency or wearing the TCVS sham. Clinical parameters obtained from the Bertec system will be recorded, including "falls" and will be compared between conditions to evaluate participant's change in balance. Participants will always be held safe with a harness secured to a mount point in the ceiling.
arm group label: Transcranial vibrating system effect
arm group type: Experimental
description: Participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. During the first 2 weeks (4 visits), 20 participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) and the other 20 participants without. The following 2 consecutive weeks (4 visits), participants will perform their PT exercises wearing the TCVS if they weren't previously, or won't wear the device during their PT exercises if they were previously.
Outcomes measured:
at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise
at the first and last visit: force plate system assessment (balance)
arm group label: Vs transcranial vibrating system sham
arm group type: Sham Comparator
description: 40 participants will be enrolled for a 4 week period and will have 2 vestibular physical therapy (PT) visits per week. Participants will perform their PT exercises (30 minutes or less if the participant is too dizzy to finish) wearing the transcranial vibration system (TCVS) at optimal vibrating frequency or wearing the TCVS at irrelevant vibrating frequency (sham). The TCVS and TCVS sham will be labeled A or B by the sponsor. The investigators and participants will not know which TCVS is optimal or sham. The sponsor will randomly assign participants TCVS A or B.
Outcomes measured:
at every visit: dizziness at the end of PT exercise (with dizziness symptom scale DSS); duration of PT exercise
at the first and last visit: force plate system assessment (balance)
intervention type: Device
intervention name: Transcranial vibrating system
description: The transcranial vibrating system (TCVS) will be worn by participants performing vestibular physical therapy (PT) exercises. The TCVS vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises. The TCVS will be set at an optimal vibration frequency as determined in a previous study.
arm group label: Transcranial vibrating system effect
arm group label: Vs transcranial vibrating system sham
intervention type: Device
intervention name: Transcranial vibrating system sham
description: A transcranial vibrating system (TCVS) sham set at an irrelevant vibrating frequency will be worn by participants performing vestibular physical therapy (PT) exercises in arm 2. The TCVS sham vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS sham will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises.
arm group label: Vs transcranial vibrating system sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Didier Depireux, PhD
role: Study Director
affiliation: Otolith Labs
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Dizziness
sharing ipd: No