<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/NCT03277521</url>
  </required_header>
  <id_info>
    <org_study_id>HM20010643</org_study_id>
    <secondary_id>FP00005482</secondary_id>
    <secondary_id>P2CHD086844</secondary_id>
    <nct_id>NCT03277521</nct_id>
  </id_info>
  <brief_title>Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia</brief_title>
  <official_title>Intermittent Theta Burst Stimulation to Promote Motor Re-education After Upper Limb Reconstruction in Tetraplegia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</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>
      A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation&#xD;
      can modulate corticomotor excitability and therefore has great rehabilitative potential for&#xD;
      individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In&#xD;
      particular, intermittent theta burst stimulation (iTBS) can increase corticomotor&#xD;
      excitability and may be a useful adjunct to physical rehabilitation to promote motor&#xD;
      re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb&#xD;
      reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant&#xD;
      or less important function to perform a more critical function. Upper limb reconstruction is&#xD;
      intended to help individuals achieve their goals related to activities of daily living and&#xD;
      independence in the community. Outcomes after reconstruction are variable and depend largely&#xD;
      on the efficacy of motor re-education of the transferred muscle to perform a new function.&#xD;
      The long-term goal of our research is to determine whether iTBS combined with physical&#xD;
      rehabilitation can improve motor re-education after reconstruction. As a first step, the&#xD;
      purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of&#xD;
      proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia:&#xD;
      individuals with and without upper limb reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in corticomotor excitability</measure>
    <time_frame>Each subject will participate in five sessions, each session separated by 3 days. After each session, changes in corticomotor excitability will be measured. Changes in excitability will be reported through study completion, an average of one month.</time_frame>
    <description>Corticomotor excitability will be measured via motor evoked potential amplitudes in response to transcranial magnetic stimulation</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Quadriplegia/Tetraplegia</condition>
  <arm_group>
    <arm_group_label>Neurologically Normal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neurologically normal subjects (i.e., nonimpaired) will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadriplegia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with quadriplegia will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadriplegia with upper limb reconstruction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with quadriplegia and upper limb reconstruction will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermittent theta burst stimulation</intervention_name>
    <description>Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.</description>
    <arm_group_label>Neurologically Normal</arm_group_label>
    <arm_group_label>Quadriplegia</arm_group_label>
    <arm_group_label>Quadriplegia with upper limb reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for all subjects with tetraplegia:&#xD;
&#xD;
          -  Injury to the lower cervical spinal cord at least one year prior to the date of&#xD;
             participation&#xD;
&#xD;
          -  Motor function classified according to the American Spinal Injury Association&#xD;
             International Standards for Neurological Classification of Spinal Cord Injury at&#xD;
             levels ranging from C5-C8&#xD;
&#xD;
        Inclusion criteria for the subjects with tetraplegia and upper limb reconstruction:&#xD;
&#xD;
        • At least one year post-operative from tendon or nerve transfer surgery of the upper limb&#xD;
&#xD;
        Exclusion criteria for all subjects with tetraplegia:&#xD;
&#xD;
          -  Presence of concurrent severe medical illness, including unhealed decubiti, use of&#xD;
             baclofen pumps, existing infection, cardiovascular disease, significant osteoporosis,&#xD;
             or a history of pulmonary complications.&#xD;
&#xD;
          -  Metal implant near head or neck&#xD;
&#xD;
          -  Risk of seizure of history of seizures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carrie L Peterson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 13, 2020</last_update_submitted>
  <last_update_submitted_qc>November 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 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>Quadriplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03277521/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03277521
org study id: HM20010643
secondary id: FP00005482
secondary id: P2CHD086844
nct id: NCT03277521
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation
      can modulate corticomotor excitability and therefore has great rehabilitative potential for
      individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In
      particular, intermittent theta burst stimulation (iTBS) can increase corticomotor
      excitability and may be a useful adjunct to physical rehabilitation to promote motor
      re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb
      reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant
      or less important function to perform a more critical function. Upper limb reconstruction is
      intended to help individuals achieve their goals related to activities of daily living and
      independence in the community. Outcomes after reconstruction are variable and depend largely
      on the efficacy of motor re-education of the transferred muscle to perform a new function.
      The long-term goal of our research is to determine whether iTBS combined with physical
      rehabilitation can improve motor re-education after reconstruction. As a first step, the
      purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of
      proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia:
      individuals with and without upper limb reconstruction.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in corticomotor excitability
time frame: Each subject will participate in five sessions, each session separated by 3 days. After each session, changes in corticomotor excitability will be measured. Changes in excitability will be reported through study completion, an average of one month.
description: Corticomotor excitability will be measured via motor evoked potential amplitudes in response to transcranial magnetic stimulation
arm group label: Neurologically Normal
arm group type: Active Comparator
description: Neurologically normal subjects (i.e., nonimpaired) will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
arm group label: Quadriplegia
arm group type: Active Comparator
description: Individuals with quadriplegia will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
arm group label: Quadriplegia with upper limb reconstruction
arm group type: Active Comparator
description: Individuals with quadriplegia and upper limb reconstruction will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
intervention type: Other
intervention name: Intermittent theta burst stimulation
description: Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.
arm group label: Neurologically Normal
arm group label: Quadriplegia
arm group label: Quadriplegia with upper limb reconstruction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carrie L Peterson, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Quadriplegia
sharing ipd: No
provided document: 