<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/NCT03227627</url>
  </required_header>
  <id_info>
    <org_study_id>APP-16-01573</org_study_id>
    <nct_id>NCT03227627</nct_id>
  </id_info>
  <brief_title>Outcomes of Using LNMES on Tracheostomized Children</brief_title>
  <official_title>Outcomes of Using LNMES on Tracheostomized Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Los Angeles</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment&#xD;
      includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist&#xD;
      on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics.&#xD;
      There is no literature available for the efficacy of LNMES in the treatment of dysphagia on&#xD;
      patients with tracheostomy tubes. The purpose of this study to determine the outcomes on&#xD;
      dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the&#xD;
      investigators aim to determine the relationship between parental stress and a child's&#xD;
      modified diet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We decided to go to another direction.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</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>One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. After the 24 sessions, participants will have a repeat MBSS and results will be scored using the Pen-Asp scale and FOIS scale. Both the control group and experimental group will answer the PSI-4 after the repeat MBSS.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.</measure>
    <time_frame>3 months. LNMES intervention will be provided for 24 sessions during this time.</time_frame>
    <description>The investigators will measure the change based on the patient's score of the Pen-Asp scale before and after the intervention provided.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)</measure>
    <time_frame>3 months. LNMES intervention will be provided for 24 sessions during this time.</time_frame>
    <description>The investigators will measure the change based on the patient's score of the FOIS before and after the intervention provided.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)</measure>
    <time_frame>3 months</time_frame>
    <description>Assess changes in parental stress level after treatments have been completed using the PSI-4 scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Trachea</condition>
  <arm_group>
    <arm_group_label>VitalStim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®. VitalStim® therapy involves the placement of electrodes to the muscles of the throat that is attached to a device that provides electrical stimulation. The intensity will be increased according to the subject's tolerance and when a &quot;therapeutic&quot; level is reached. Signs of reaching therapeutic level include changes in audible quality of swallows, triggers of swallows, and changes in quality of voice. This therapy is to be performed by a VitalStim® certified practitioner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VitalStim</intervention_name>
    <description>One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®.</description>
    <arm_group_label>VitalStim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Therapy</intervention_name>
    <description>The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.</description>
    <arm_group_label>Traditional therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        PATIENT COHORT&#xD;
&#xD;
          -  Children between 0-4 years 11 months&#xD;
&#xD;
          -  Currently have tracheostomy tubes&#xD;
&#xD;
          -  MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½&#xD;
             nectar-thick, nectar-thick or honey-thick liquids.&#xD;
&#xD;
          -  The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½&#xD;
             nectar-thick liquids, or no liquids by mouth.&#xD;
&#xD;
          -  Able to tolerate a voice valve PARENT COHORT&#xD;
&#xD;
          -  At least one primary caregiver of a qualifying child (see Child cohort).&#xD;
&#xD;
          -  Parent/caregiver must be at least 18 years of age or older, provide primary care, and&#xD;
             have medical decision making rights for the child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        PATIENT COHORT&#xD;
&#xD;
          -  Children who are not on modified diets or using a g-tube as an alternate means of&#xD;
             nutrition&#xD;
&#xD;
          -  Children with suspected or diagnosed heart problems&#xD;
&#xD;
          -  Children with suspected or diagnosed epilepsy&#xD;
&#xD;
          -  Children with a tendency to hemorrhage following acute trauma or fracture&#xD;
&#xD;
          -  Children who have undergone recent surgical procedures when muscle contraction may&#xD;
             disrupt the healing process&#xD;
&#xD;
          -  Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over&#xD;
             active infection and 4) over areas of skin which lack normal sensation&#xD;
&#xD;
          -  Children with difficulty tolerating tactile stimulation and tolerate the whole&#xD;
             duration of the LNMES sessions.&#xD;
&#xD;
          -  Children with difficulty tolerating tactile sensory stimulation such as tape and&#xD;
             electrodes on the anterior aspect of the neck.&#xD;
&#xD;
        PARENT COHORT&#xD;
&#xD;
          -  The caregiver that does not provide the primary care of the child and does not have&#xD;
             medical decision making right&#xD;
&#xD;
          -  Parents under 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Days</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aviril Sepulveda</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Los Angeles</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</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>Tracheal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03227627
org study id: APP-16-01573
nct id: NCT03227627
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment
      includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist
      on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics.
      There is no literature available for the efficacy of LNMES in the treatment of dysphagia on
      patients with tracheostomy tubes. The purpose of this study to determine the outcomes on
      dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the
      investigators aim to determine the relationship between parental stress and a child's
      modified diet.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy. After the 24 sessions, participants will have a repeat MBSS and results will be scored using the Pen-Asp scale and FOIS scale. Both the control group and experimental group will answer the PSI-4 after the repeat MBSS.
primary purpose: Treatment
masking: None (Open Label)
measure: Assess Quality of Swallow during the MBSS (Modified Barium Swallow Study) using the Pen-Asp scale.
time frame: 3 months. LNMES intervention will be provided for 24 sessions during this time.
description: The investigators will measure the change based on the patient's score of the Pen-Asp scale before and after the intervention provided.
measure: Assess safety and adequate functional oral intake using the FOIS (Functional Oral Intake Scale)
time frame: 3 months. LNMES intervention will be provided for 24 sessions during this time.
description: The investigators will measure the change based on the patient's score of the FOIS before and after the intervention provided.
measure: Assess Change in Parental Stress Level using the PSI-4 (Parent Stress Index-4)
time frame: 3 months
description: Assess changes in parental stress level after treatments have been completed using the PSI-4 scale.
arm group label: VitalStim
arm group type: Experimental
description: One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®. VitalStim® therapy involves the placement of electrodes to the muscles of the throat that is attached to a device that provides electrical stimulation. The intensity will be increased according to the subject's tolerance and when a "therapeutic" level is reached. Signs of reaching therapeutic level include changes in audible quality of swallows, triggers of swallows, and changes in quality of voice. This therapy is to be performed by a VitalStim® certified practitioner.
arm group label: Traditional therapy
arm group type: Active Comparator
description: The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.
intervention type: Device
intervention name: VitalStim
description: One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®.
arm group label: VitalStim
intervention type: Other
intervention name: Traditional Therapy
description: The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.
arm group label: Traditional therapy
criteria: 
gender: All
minimum age: 30 Days
maximum age: 5 Years
healthy volunteers: No
last name: Aviril Sepulveda
role: Principal Investigator
affiliation: Children's Hospital Los Angeles
country: United States
responsible party type: Sponsor
mesh term: Tracheal Diseases
sharing ipd: Undecided