<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/NCT04470245</url>
  </required_header>
  <id_info>
    <org_study_id>PL19/122843</org_study_id>
    <nct_id>NCT04470245</nct_id>
  </id_info>
  <brief_title>Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study</brief_title>
  <official_title>Cubital Tunnel Syndrome and Diffusion Tensor Magnetic Resonance Imaging: A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow&#xD;
      (colloquially termed the &quot;funny bone&quot;). CTS affects up to 6% of the population and 6000&#xD;
      patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS,&#xD;
      although up to 30% of patients do not improve. Therefore, there is a pressing need to develop&#xD;
      a reliable test to diagnose CTS to improve the selection of patients for surgery.&#xD;
&#xD;
      New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of&#xD;
      nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging&#xD;
      (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable&#xD;
      diagnostic of CTS, improving the selection of patients for surgery.&#xD;
&#xD;
      The study will include healthy volunteers (to refine the scanning sequence) and patients&#xD;
      undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using&#xD;
      cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived&#xD;
      diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to&#xD;
      patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction&#xD;
      studies).&#xD;
&#xD;
      Leeds is the ideal location for this research because a) Leeds institutions are the most&#xD;
      highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre&#xD;
      for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally&#xD;
      recognised centre of excellence for complex upper limb surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel</measure>
    <time_frame>60 minutes</time_frame>
    <description>change following surgical decompression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cubital Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients undergoing surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>magnetic resonance imaging (MRI)</intervention_name>
    <description>Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques.</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients undergoing surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at&#xD;
             the elbow for cubital tunnel syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to get into the MRI scanner due to habitus or claustrophobia&#xD;
&#xD;
          -  Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)&#xD;
&#xD;
          -  Intraocular or intracranial metallic foreign bodies&#xD;
&#xD;
          -  Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve&#xD;
             stimulators, etc) which are not MRI safe or conditional.&#xD;
&#xD;
          -  Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or&#xD;
             fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and&#xD;
             inductive heating generated by alternating magnetic fields.&#xD;
&#xD;
          -  Any metallic implants in the elbow&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ryckie Wade, MBBS DipHR MClinEd MRCS FHEA</last_name>
    <email>ryckiewade@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryckie Wade</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 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>Cubital 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/NCT04470245
org study id: PL19/122843
nct id: NCT04470245
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow
      (colloquially termed the "funny bone"). CTS affects up to 6% of the population and 6000
      patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS,
      although up to 30% of patients do not improve. Therefore, there is a pressing need to develop
      a reliable test to diagnose CTS to improve the selection of patients for surgery.

      New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of
      nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging
      (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable
      diagnostic of CTS, improving the selection of patients for surgery.

      The study will include healthy volunteers (to refine the scanning sequence) and patients
      undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using
      cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived
      diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to
      patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction
      studies).

      Leeds is the ideal location for this research because a) Leeds institutions are the most
      highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre
      for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally
      recognised centre of excellence for complex upper limb surgery.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel
time frame: 60 minutes
description: change following surgical decompression.
arm group label: Healthy volunteers
arm group type: Active Comparator
arm group label: Patients undergoing surgery
arm group type: Active Comparator
description: We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.
intervention type: Diagnostic Test
intervention name: magnetic resonance imaging (MRI)
description: Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques.
arm group label: Healthy volunteers
arm group label: Patients undergoing surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ryckie Wade, MBBS DipHR MClinEd MRCS FHEA
email: ryckiewade@gmail.com
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cubital Tunnel Syndrome
mesh term: Syndrome