xml: <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/NCT06016049</url>
    </required_header>
    <id_info>
      <org_study_id>210817</org_study_id>
      <nct_id>NCT06016049</nct_id>
    </id_info>
    <brief_title>Cerebral Changes Following CTS Treated With Guided Plasticity</brief_title>
    <official_title>Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Skane</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Region Skane</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with&#xD;
        unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm&#xD;
        deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated&#xD;
        outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome&#xD;
        questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH).&#xD;
        Clinically patients were assessed for tactile discrimination and dexterity and nerve&#xD;
        conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with&#xD;
        functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline,&#xD;
        after 90 min of initial treatment, and after 8 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2009</start_date>
    <completion_date type="Actual">November 1, 2015</completion_date>
    <primary_completion_date type="Actual">November 1, 2015</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>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Boston Carpal Tunnel Syndrome Symptom Severity Score</measure>
      <time_frame>8 weeks</time_frame>
      <description>score between 1 and 5, with higher scores indicating worse symptoms or function</description>
    </primary_outcome>
    <primary_outcome>
      <measure>functional MRI activation affected vs healthy side (more activation voxels means more active brain area)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>quick-DASH upper extremity symptom score</measure>
      <time_frame>8 weeks</time_frame>
      <description>score between 1-5, higher scores indicating less symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2 Point Discrimination (2PD)</measure>
      <time_frame>8 weeks</time_frame>
      <description>mean value of 3 measures indicating touch threshold</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory conduction velocity</measure>
      <time_frame>8 weeks</time_frame>
      <description>Sensory Nerve Conduction Velocity from nerve conduction studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory conduction amplitude</measure>
      <time_frame>8 weeks</time_frame>
      <description>Sensory Nerve Conduction Amplitude from nerve conduction studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>functional MRI dig 1+2</measure>
      <time_frame>8 weeks</time_frame>
      <description>comparison between activation using interaction contrast in S1sensory cortex of the</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>functional MRI dig 5</measure>
      <time_frame>8 weeks</time_frame>
      <description>comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <arm_group>
      <arm_group_label>EMLA®</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Skin cream</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EMLA® adjuvant</intervention_name>
      <description>cutaneous forearm deafferentation</description>
      <arm_group_label>EMLA®</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sensory training</intervention_name>
      <description>Sensibility training of the median nerve</description>
      <arm_group_label>EMLA®</arm_group_label>
      <arm_group_label>Skin cream</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  symptoms of CTS for more than 3 months&#xD;
  &#xD;
            -  classic or probable CTS according to Katz' hand diagram (2, 27)&#xD;
  &#xD;
            -  clinical signs of unilateral CTS with a positive Tinel's and Phalen's test&#xD;
  &#xD;
            -  age between 18 and 70 years&#xD;
  &#xD;
            -  nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity&#xD;
               for the median nerve across the wrist of 40 m/s or less on the affected side and of&#xD;
               more than 43 m/s on the contralateral side&#xD;
  &#xD;
            -  no contraindications for MR examinations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  bilateral symptoms&#xD;
  &#xD;
            -  having been operated for CTS previously&#xD;
  &#xD;
            -  prior wrist or carpal fracture&#xD;
  &#xD;
            -  diabetes&#xD;
  &#xD;
            -  thyroid disease&#xD;
  &#xD;
            -  rheumatoid arthritis&#xD;
  &#xD;
            -  neurological disease&#xD;
  &#xD;
            -  drug abuse&#xD;
  &#xD;
            -  complete conduction block on electroneurography or prior regular exposure to hand-held&#xD;
               vibrating tools.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Magnus Flondell, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Translational Sciences Malmö, Lund University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anders Björkman, MD, Prof.</last_name>
      <role>Study Chair</role>
      <affiliation>Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University</affiliation>
    </overall_official>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Magnetic Resonance Imaging</keyword>
    <keyword>Somatosensory Cortex</keyword>
    <keyword>Anesthesia</keyword>
    <keyword>Hand</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>data can be shared upon reasonable demand after personal contact.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016049
  org study id: 210817
  nct id: NCT06016049
  lead sponsor: 
  has dmc: No
  is fda regulated device: No
  70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with
        unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm
        deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated
        outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome
        questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH).
        Clinically patients were assessed for tactile discrimination and dexterity and nerve
        conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with
        functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline,
        after 90 min of initial treatment, and after 8 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Outcomes Assessor)
  measure: Boston Carpal Tunnel Syndrome Symptom Severity Score
  time frame: 8 weeks
  description: score between 1 and 5, with higher scores indicating worse symptoms or function
  measure: functional MRI activation affected vs healthy side (more activation voxels means more active brain area)
  time frame: 8 weeks
  description: The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)
  measure: quick-DASH upper extremity symptom score
  time frame: 8 weeks
  description: score between 1-5, higher scores indicating less symptoms
  measure: 2 Point Discrimination (2PD)
  time frame: 8 weeks
  description: mean value of 3 measures indicating touch threshold
  measure: Sensory conduction velocity
  time frame: 8 weeks
  description: Sensory Nerve Conduction Velocity from nerve conduction studies
  measure: Sensory conduction amplitude
  time frame: 8 weeks
  description: Sensory Nerve Conduction Amplitude from nerve conduction studies
  measure: functional MRI dig 1+2
  time frame: 8 weeks
  description: comparison between activation using interaction contrast in S1sensory cortex of the
  measure: functional MRI dig 5
  time frame: 8 weeks
  description: comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)
  arm group label: EMLA®
  arm group type: Active Comparator
  description: adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity
  arm group label: Skin cream
  arm group type: Placebo Comparator
  description: skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training
  intervention type: Other
  intervention name: EMLA® adjuvant
  description: cutaneous forearm deafferentation
  arm group label: EMLA®
  intervention type: Behavioral
  intervention name: Sensory training
  description: Sensibility training of the median nerve
  arm group label: EMLA®
  arm group label: Skin cream
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Magnus Flondell, MD PhD
  role: Principal Investigator
  affiliation: Institute of Translational Sciences Malmö, Lund University
  last name: Anders Björkman, MD, Prof.
  role: Study Chair
  affiliation: Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University
  responsible party type: Sponsor
  mesh term: Carpal Tunnel Syndrome
  mesh term: Syndrome
  sharing ipd: No
  ipd description: data can be shared upon reasonable demand after personal contact.