<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/NCT04504344</url>
  </required_header>
  <id_info>
    <org_study_id>NC NM4R Pilot Project Program</org_study_id>
    <nct_id>NCT04504344</nct_id>
  </id_info>
  <brief_title>Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction</brief_title>
  <official_title>Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arcadia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arcadia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quadriceps muscle dysfunction persists for years after anterior cruciate ligament&#xD;
      reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement&#xD;
      patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and&#xD;
      higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the&#xD;
      brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is&#xD;
      reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that&#xD;
      current rehabilitation strategies may not be addressing potential maladaptive changes in&#xD;
      central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability&#xD;
      (i.e. central drive) and has the potential to address alterations in central drive and&#xD;
      quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the&#xD;
      effects of anodal tDCS on central drive and quadriceps muscle performance in patients after&#xD;
      ACLR, and 2) determine the relationship between central drive and quadriceps muscle&#xD;
      performance in patients after ACLR. Central drive will be defined by two measures: 1) active&#xD;
      motor thresholds, and 2) slope of a stimulus response curve. Quadriceps muscle performance&#xD;
      will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque&#xD;
      development (RTD). For purpose 1 the investigators hypothesize that measures of central drive&#xD;
      and quadriceps muscle performance will increase with administration of active anodal tDCS&#xD;
      compared to no change with sham tDCS. For purpose 2 the investigators hypothesize that both&#xD;
      measures of central drive will be associated with both measures of quadriceps performance,&#xD;
      with a stronger association between central drive and RTD. Following a cross-over design&#xD;
      patients 3-6 months from ACLR will receive active and sham anodal tDCS at different sessions&#xD;
      separated by 7-10 days while they ride a stationary bike for 20 minutes. Bike position and&#xD;
      intensity will be standardized for all patients to maximize quadriceps activity. Findings&#xD;
      from this study will expand our basic science knowledge on how tDCS effects different aspects&#xD;
      of corticospinal excitability and quadriceps strength, and lead to subsequent studies to&#xD;
      determine the effects of multiple sessions of tDCS on corticospinal excitability and&#xD;
      quadriceps muscle performance in patients recovering from ACLR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>isometric quadriceps torque</measure>
    <time_frame>3-6 months after ACL Reconstruction</time_frame>
    <description>Nm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quadriceps rate of torque development</measure>
    <time_frame>3-6 months after ACL Reconstruction</time_frame>
    <description>Nm/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corticospinal excitability - active motor threshold</measure>
    <time_frame>3-6 months after ACL Reconstruction</time_frame>
    <description>percent maximal stimulator output</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Corticospinal excitability - slope of the stimulus response curve</measure>
    <time_frame>3-6 months after ACL Reconstruction</time_frame>
    <description>motor evoked potential/percent active motor threshold</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <condition>Quadriceps Muscle Weakness</condition>
  <condition>Transcranial Direct Current Stimulation</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active tDCS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)</intervention_name>
    <description>We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Underwent primary ACL reconstruction within 3-6 months&#xD;
&#xD;
        Exclusion Criteria include:&#xD;
&#xD;
          -  multiple ligament reconstruction&#xD;
&#xD;
          -  osteo-chondral procedures&#xD;
&#xD;
          -  any previous lower extremity surgery&#xD;
&#xD;
          -  previous ACL injury&#xD;
&#xD;
          -  Metal or implants in the head or neck&#xD;
&#xD;
          -  history of neurological disease, seizures, severe migraines, and concussion within the&#xD;
             last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ryan Zarzycki</name>
      <address>
        <city>Glenside</city>
        <state>Pennsylvania</state>
        <zip>19038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arcadia University</investigator_affiliation>
    <investigator_full_name>Ryan Zarzycki</investigator_full_name>
    <investigator_title>Assistant Professor Department of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>corticospinal excitability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04504344/Prot_001.pdf</document_url>
    </provided_document>
    <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>May 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04504344/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/NCT04504344
org study id: NC NM4R Pilot Project Program
nct id: NCT04504344
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Quadriceps muscle dysfunction persists for years after anterior cruciate ligament
      reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement
      patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and
      higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the
      brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is
      reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that
      current rehabilitation strategies may not be addressing potential maladaptive changes in
      central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability
      (i.e. central drive) and has the potential to address alterations in central drive and
      quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the
      effects of anodal tDCS on central drive and quadriceps muscle performance in patients after
      ACLR, and 2) determine the relationship between central drive and quadriceps muscle
      performance in patients after ACLR. Central drive will be defined by two measures: 1) active
      motor thresholds, and 2) slope of a stimulus response curve. Quadriceps muscle performance
      will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque
      development (RTD). For purpose 1 the investigators hypothesize that measures of central drive
      and quadriceps muscle performance will increase with administration of active anodal tDCS
      compared to no change with sham tDCS. For purpose 2 the investigators hypothesize that both
      measures of central drive will be associated with both measures of quadriceps performance,
      with a stronger association between central drive and RTD. Following a cross-over design
      patients 3-6 months from ACLR will receive active and sham anodal tDCS at different sessions
      separated by 7-10 days while they ride a stationary bike for 20 minutes. Bike position and
      intensity will be standardized for all patients to maximize quadriceps activity. Findings
      from this study will expand our basic science knowledge on how tDCS effects different aspects
      of corticospinal excitability and quadriceps strength, and lead to subsequent studies to
      determine the effects of multiple sessions of tDCS on corticospinal excitability and
      quadriceps muscle performance in patients recovering from ACLR.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: isometric quadriceps torque
time frame: 3-6 months after ACL Reconstruction
description: Nm
measure: quadriceps rate of torque development
time frame: 3-6 months after ACL Reconstruction
description: Nm/s
measure: Corticospinal excitability - active motor threshold
time frame: 3-6 months after ACL Reconstruction
description: percent maximal stimulator output
measure: Corticospinal excitability - slope of the stimulus response curve
time frame: 3-6 months after ACL Reconstruction
description: motor evoked potential/percent active motor threshold
arm group label: Active tDCS
arm group type: Experimental
description: Active tDCS
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham tDCS
intervention type: Device
intervention name: Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)
description: We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.
arm group label: Active tDCS
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Arcadia University
investigator full name: Ryan Zarzycki
investigator title: Assistant Professor Department of Physical Therapy
mesh term: Muscle Weakness
sharing ipd: No
provided document: 
provided document: 