<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/NCT02196220</url>
  </required_header>
  <id_info>
    <org_study_id>59910</org_study_id>
    <nct_id>NCT02196220</nct_id>
  </id_info>
  <brief_title>Ultrasonographic Assessment of Carpal Tunnel Syndrome</brief_title>
  <official_title>Ultrasonographic Assessment of Carpal Tunnel Syndrome in Children With Mucopolysaccharidosis and Comparison to Median Nerve Anatomy in Healthy Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo&#xD;
      syndromes. These patients have a genetic enzyme deficiency that results in the inability to&#xD;
      degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell&#xD;
      enlargement and subsequent dysfunction. The accumulation occurs in all tissues including&#xD;
      cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits,&#xD;
      and various other orthopaedic manifestations [Van Heest, White]. These children often suffer&#xD;
      from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal&#xD;
      tunnel syndrome is almost always present, but may not become apparent until symptoms are&#xD;
      severe and loss of function has occurred. The current gold standard for diagnosis consists of&#xD;
      electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general&#xD;
      anesthetic [Khanna].&#xD;
&#xD;
      Primary Objective: The investigators plan to correlate EMG findings and median nerve&#xD;
      cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is&#xD;
      that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove&#xD;
      to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the&#xD;
      need for EMG studies and anesthesia.&#xD;
&#xD;
      Secondary Objective: The investigators want to determine the cross-sectional area of the&#xD;
      median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The&#xD;
      investigators plan to evaluate a cohort of healthy children to determine a normal&#xD;
      cross-sectional area of the median nerve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Median nerve cross-sectional area in children with mucopolysaccharidosis and a cohort of healthy children, ages 3-12.</measure>
    <time_frame>6-weeks after open carpal tunnel release</time_frame>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study Size: *150 total which includes the following:&#xD;
&#xD;
        Arm 1: 25 Children with mucopolysaccharidosis&#xD;
&#xD;
        Arm 2: 100 Control Group - Healthy children ages 3-12 with no previous history of upper&#xD;
        extremity trauma or history of mucopolysaccharidosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the first arm of the study (25 participants):&#xD;
&#xD;
          -  Children with mucopolysaccharidosis presenting to the senior author's clinic with&#xD;
             signs or symptoms of carpal tunnel syndrome will be enrolled to receive both an EMG&#xD;
             and carpal tunnel ultrasound of the upper extremities.&#xD;
&#xD;
        For the second arm of the study (100 participants):&#xD;
&#xD;
          -  Healthy children ages 3-12 with no acute upper extremity trauma or history of&#xD;
             mucopolysaccharidosis.&#xD;
&#xD;
          -  25 additional participants requested in case of inconclusive ultrasound results,&#xD;
             patient removal, or other unusable results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        First arm:&#xD;
&#xD;
          -  Children with mucopolysaccharidosis who have undergone previous treatment for carpal&#xD;
             tunnel syndrome.&#xD;
&#xD;
        Second arm:&#xD;
&#xD;
          -  Acute (&lt;3month) wrist or hand surgery/injuries.&#xD;
&#xD;
          -  Unable to obtain parental consent or patient assent.&#xD;
&#xD;
          -  History of mucopolysaccharidosis.&#xD;
&#xD;
          -  Non-english speaking.&#xD;
&#xD;
          -  Cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas T Hutchinson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Orthopedic Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Moeller, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah Orthopedic Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah/Primary Children's Medical Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Douglas Hutchinson</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196220
org study id: 59910
nct id: NCT02196220
lead sponsor: 
has dmc: No
Mucopolysaccharidosis are lysosomal storage disorders such as Hunter, Hurler, and Sanfilippo
      syndromes. These patients have a genetic enzyme deficiency that results in the inability to
      degrade glycosaminoglycans. The glycosaminoglycans accumulate in lysosomes causing cell
      enlargement and subsequent dysfunction. The accumulation occurs in all tissues including
      cartilage, joint capsule, and tendons and can lead to carpal tunnel syndrome, trigger digits,
      and various other orthopaedic manifestations [Van Heest, White]. These children often suffer
      from severe cognitive impairment and are often unable to communicate pain or numbness. Carpal
      tunnel syndrome is almost always present, but may not become apparent until symptoms are
      severe and loss of function has occurred. The current gold standard for diagnosis consists of
      electromyographic (EMG) and nerve conduction velocity (NCV) studies under sedation or general
      anesthetic [Khanna].

      Primary Objective: The investigators plan to correlate EMG findings and median nerve
      cross-sectional area in children with mucopolysaccharidosis. The investigators hypothesis is
      that ultrasonography of the carpal tunnel in patients with mucopolysaccharidosis will prove
      to be an effective, reliable, and safe method to evaluate the median nerve, thus avoiding the
      need for EMG studies and anesthesia.

      Secondary Objective: The investigators want to determine the cross-sectional area of the
      median nerve using ultrasonography in a cohort of healthy children, ages 3-12. The
      investigators plan to evaluate a cohort of healthy children to determine a normal
      cross-sectional area of the median nerve.
observational model: Cohort
time perspective: Prospective
measure: Median nerve cross-sectional area in children with mucopolysaccharidosis and a cohort of healthy children, ages 3-12.
time frame: 6-weeks after open carpal tunnel release
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Douglas T Hutchinson, M.D.
role: Principal Investigator
affiliation: University of Utah Orthopedic Center
last name: Amy Moeller, M.D.
role: Principal Investigator
affiliation: University of Utah Orthopedic Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Douglas Hutchinson
investigator title: M.D.
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome