<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/NCT03239418</url>
  </required_header>
  <id_info>
    <org_study_id>BRCRC2016_001</org_study_id>
    <nct_id>NCT03239418</nct_id>
  </id_info>
  <brief_title>NMES to Improve Eyelid Functions in Cranial Nerve (CN) III and VII Palsy</brief_title>
  <acronym>EyeStim</acronym>
  <official_title>A Novel Treatment Using Neuromuscular Electrical Stimulation to Improve Eyelid Function in Patients With CN III and CN VII Palsy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooks Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brooks Rehabilitation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic brain injury, stroke and other neurological conditions may result in weakness of&#xD;
      the muscles that either open or close the eye. This is generally a result of impaired&#xD;
      functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye&#xD;
      opening or closing are either invasive or largely ineffective. This study tests a noninvasive&#xD;
      means of improving eyelid opening and closing by applying a previously demonstrated safe and&#xD;
      effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling&#xD;
      eyelid movement. Participants in this study will either receive the investigational NMES&#xD;
      protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome&#xD;
      for this study is the participants' ability to open or close their affected eye. Secondary&#xD;
      outcomes include additional measures of eye and corneal health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">October 16, 2019</completion_date>
  <primary_completion_date type="Actual">October 16, 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>
    <intervention_model_description>Active treatment vs. Sham control</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants in treatment and sham group undergo all of the same procedures except a sham NMES treatment is provided to the control group. Only the treating clinician is aware of group allocation. The investigator and outcomes assessor are unaware of group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal reflex distance-1 (MRD-1)</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of eyelid function for participants with CN III or CN VII palsy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Palpebral fissure height</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of eyelid function for participants with CN III or CN VII palsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life - BREF (WHOQOL-BREF)</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of Quality of Life for participants with CN III or CN VII palsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper eyelid crease distance</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of eyelid function in participants with CN III or CN VII palsy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Distance visual acuity</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of overall eye health and function</description>
  </other_outcome>
  <other_outcome>
    <measure>Distance alternate cover test.</measure>
    <time_frame>Within 1 week of last treatment.</time_frame>
    <description>Measure of overall eye health and function</description>
  </other_outcome>
  <other_outcome>
    <measure>Pupil test</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of overall eye health and function</description>
  </other_outcome>
  <other_outcome>
    <measure>Oculomotor exam</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of overall eye health and function in participants with CN III palsy</description>
  </other_outcome>
  <other_outcome>
    <measure>Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS).</measure>
    <time_frame>Within 1 week of last treatment session.</time_frame>
    <description>Measure of ophthalmic involvement in facial function in participants with CN VII palsy</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Blepharoptosis</condition>
  <condition>Lagophthalmos</condition>
  <arm_group>
    <arm_group_label>EyeStim Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive an active NMES treatment to the targeted muscles controlling eyelid function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuromuscular electrical stimulation</intervention_name>
    <description>A low level electrical current is applied to the muscle that control eyelid function through small electrodes applied to the skin over the target muscles. Treatment is applied daily for 5 consecutive days and exercises for eyelid function are performed in conjunction with the stimulation.</description>
    <arm_group_label>EyeStim Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham neuromuscular electrical stimulation</intervention_name>
    <description>Electrodes are applied to the skin over the target muscles and patient perform the exercises for eyelid function for 5 consecutive days just as in the experimental group, However participants do not receive the electrical stimulation. Due to the low intensity of the stimulation all participants regardless of group allocation are told they may or may not feel the electrical stimulation.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cranial nerve III (oculomotor nerve) and/or cranial nerve IV (facial nerve) palsy.&#xD;
&#xD;
          -  Able to read and communicate in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Idiopathic onset of CN III and/or CN IV palsy.&#xD;
&#xD;
          -  Traumatic injury to the eye or eyelid.&#xD;
&#xD;
          -  Active wounds in the treatment area.&#xD;
&#xD;
          -  Presence of swelling or infection in or surrounding the affected eye.&#xD;
&#xD;
          -  Diminished sensation in the area to be treated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Ngo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brooks Rehabilitation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brooks Rehabilitation</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NMES</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharoptosis</mesh_term>
    <mesh_term>Lagophthalmos</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/NCT03239418
org study id: BRCRC2016_001
nct id: NCT03239418
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Traumatic brain injury, stroke and other neurological conditions may result in weakness of
      the muscles that either open or close the eye. This is generally a result of impaired
      functioning of the oculomotor or facial cranial nerves. Current treatments to improve eye
      opening or closing are either invasive or largely ineffective. This study tests a noninvasive
      means of improving eyelid opening and closing by applying a previously demonstrated safe and
      effective neuromuscular electrical stimulation (NMES) intervention to the muscles controlling
      eyelid movement. Participants in this study will either receive the investigational NMES
      protocol 30 min per day for five days or a sham NMES for the same period. The primary outcome
      for this study is the participants' ability to open or close their affected eye. Secondary
      outcomes include additional measures of eye and corneal health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Active treatment vs. Sham control
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participants in treatment and sham group undergo all of the same procedures except a sham NMES treatment is provided to the control group. Only the treating clinician is aware of group allocation. The investigator and outcomes assessor are unaware of group allocation.
measure: Marginal reflex distance-1 (MRD-1)
time frame: Within 1 week of last treatment session.
description: Measure of eyelid function for participants with CN III or CN VII palsy
measure: Palpebral fissure height
time frame: Within 1 week of last treatment session.
description: Measure of eyelid function for participants with CN III or CN VII palsy
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
time frame: Within 1 week of last treatment session.
description: Measure of Quality of Life for participants with CN III or CN VII palsy
measure: Upper eyelid crease distance
time frame: Within 1 week of last treatment session.
description: Measure of eyelid function in participants with CN III or CN VII palsy
measure: Distance visual acuity
time frame: Within 1 week of last treatment session.
description: Measure of overall eye health and function
measure: Distance alternate cover test.
time frame: Within 1 week of last treatment.
description: Measure of overall eye health and function
measure: Pupil test
time frame: Within 1 week of last treatment session.
description: Measure of overall eye health and function
measure: Oculomotor exam
time frame: Within 1 week of last treatment session.
description: Measure of overall eye health and function in participants with CN III palsy
measure: Cornea, Static Asymmetry, Dynamic Function, Synkinesis Classification Scale (CADS).
time frame: Within 1 week of last treatment session.
description: Measure of ophthalmic involvement in facial function in participants with CN VII palsy
arm group label: EyeStim Group
arm group type: Experimental
description: Receive an active NMES treatment to the targeted muscles controlling eyelid function.
arm group label: Control Group
arm group type: Sham Comparator
description: Undergo all the same procedures as the EyeStim group except receive a sham NMES treatment.
intervention type: Device
intervention name: Neuromuscular electrical stimulation
description: A low level electrical current is applied to the muscle that control eyelid function through small electrodes applied to the skin over the target muscles. Treatment is applied daily for 5 consecutive days and exercises for eyelid function are performed in conjunction with the stimulation.
arm group label: EyeStim Group
intervention type: Device
intervention name: Sham neuromuscular electrical stimulation
description: Electrodes are applied to the skin over the target muscles and patient perform the exercises for eyelid function for 5 consecutive days just as in the experimental group, However participants do not receive the electrical stimulation. Due to the low intensity of the stimulation all participants regardless of group allocation are told they may or may not feel the electrical stimulation.
arm group label: Control Group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Ngo, MD
role: Principal Investigator
affiliation: Brooks Rehabilitation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Blepharoptosis
mesh term: Lagophthalmos
sharing ipd: No