<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/NCT03752749</url>
  </required_header>
  <id_info>
    <org_study_id>STU00103487</org_study_id>
    <nct_id>NCT03752749</nct_id>
  </id_info>
  <brief_title>Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI</brief_title>
  <official_title>Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</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>
      The objective of this study is to examine the effects of mild acute intermittent hypoxia&#xD;
      (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance&#xD;
      in persons with spinal cord injury (SCI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2014</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Isometric Ankle Plantar Flexion strength</measure>
    <time_frame>60 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Prednisolone + Acute Intermittent Hypoxia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Acute Intermittent Hypoxia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prednisolone + Acute Intermittent Hypoxia</intervention_name>
    <description>Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia</description>
    <arm_group_label>Prednisolone + Acute Intermittent Hypoxia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo + Acute Intermittent Hypoxia</intervention_name>
    <description>Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia</description>
    <arm_group_label>Placebo + Acute Intermittent Hypoxia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spinal cord lesion at the level of C4 or below.&#xD;
&#xD;
          -  Incomplete spinal cord injury ASIA (American Spinal Injury Association) Impairment&#xD;
             Scale classification C or D. ASIA C or D classification requires that individuals have&#xD;
             detectable motor function below the level of spinal injury and have preserved&#xD;
             sensation of the sacral segments S4-S5 (anal sphincter).&#xD;
&#xD;
          -  Age between 18 and 65 years.&#xD;
&#xD;
          -  Medically stable with medical clearance to participate.&#xD;
&#xD;
          -  SCI due to non-progressive etiology.&#xD;
&#xD;
          -  More than 6 months since initial SCI. We plan to choose subjects greater that six&#xD;
             months post-injury, to ensure minimal confounding effects of spontaneous neurological&#xD;
             recovery during the experiments. This will mean that changes in motor performance are&#xD;
             due to the interventions associated with the research study.&#xD;
&#xD;
          -  Subjects must have active and passive ROM at the ankle from 10 degrees dorsiflexion to&#xD;
             30 degrees plantar flexion, 0 to 120 degrees of knee flexion, 90 degrees of hip&#xD;
             flexion, and 10 degrees of hip extension in order to be positioned correctly for motor&#xD;
             performance testing.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of severe medical illness, including cardiac disease, uncontrolled high blood&#xD;
             pressure, restrictive or obstructive pulmonary disease, significant osteoporosis or&#xD;
             history of fracture following SCI, or history of lower limb peripheral nerve injury.&#xD;
&#xD;
          -  Individuals with uncontrolled diabetes mellitus, unhealed decubitus ulcers, active&#xD;
             heterotopic ossification, rheumatologic disease or inflammatory arthritis, presence of&#xD;
             a deep venous thrombosis, cancer, or active infection will be excluded, as these&#xD;
             conditions can cause systemic inflammation independent of spinal cord injury.&#xD;
&#xD;
          -  Patients may not be receiving any other investigational agents.&#xD;
&#xD;
          -  Individuals with tracheostomy, asthma, or recent or current pulmonary infection will&#xD;
             be excluded.&#xD;
&#xD;
          -  Women who are pregnant or nursing will be excluded, as the potential effects of&#xD;
             intermittent hypoxia on pregnant women and fetus are unknown.&#xD;
&#xD;
          -  Subjects will also be excluded if they are currently taking NSAIDs, steroids, or&#xD;
             disease-modifying anti-rheumatic drugs (DMARDs). Participation is allowed if the&#xD;
             subject and his/her physician agree to suspend all NSAIDs for a minimum of a 14-day&#xD;
             washout period prior to study evaluation and for the duration of the study.&#xD;
             Individuals taking oral steroids, DMARDs will be excluded from the study due to the&#xD;
             potential risks of abruptly discontinuing these agents.&#xD;
&#xD;
          -  Individuals will be excluded if they have a history of severe adverse reaction or&#xD;
             allergic response to prednisolone in the past, history of stomach or intestinal&#xD;
             ulcers, bleeding problems, chronic kidney disease, drink more than 3 alcoholic&#xD;
             beverages per day, or are currently taking blood thinners. Excluding these individuals&#xD;
             will limit the potential for having an adverse reaction to the anti-inflammatory&#xD;
             administered in the study.&#xD;
&#xD;
          -  Individuals receiving intrathecal baclofen will be excluded. Individuals prescribed&#xD;
             medications other than intrathecal baclofen for alleviation of spastic motor behaviors&#xD;
             will be excluded unless both the subject and his/her physician agree to cease all such&#xD;
             medications for a 14-day minimum washout period prior to participation and for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Individuals will be excluded if they are taking antifungal ointments, estradiols or&#xD;
             estrogens, rifampin, phenytoin, barbiturates or bupropion as these drugs can potential&#xD;
             interact with prednisolone. See &quot;concomitant medications&quot; section below.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Zev Rymer</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03752749
org study id: STU00103487
nct id: NCT03752749
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to examine the effects of mild acute intermittent hypoxia
      (AIH) in combination with an anti-inflammatory drug (i.e. prednisolone) on motor performance
      in persons with spinal cord injury (SCI).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Isometric Ankle Plantar Flexion strength
time frame: 60 minutes
arm group label: Prednisolone + Acute Intermittent Hypoxia
arm group type: Experimental
arm group label: Placebo + Acute Intermittent Hypoxia
arm group type: Placebo Comparator
intervention type: Other
intervention name: Prednisolone + Acute Intermittent Hypoxia
description: Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia
arm group label: Prednisolone + Acute Intermittent Hypoxia
intervention type: Other
intervention name: Placebo + Acute Intermittent Hypoxia
description: Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia
arm group label: Placebo + Acute Intermittent Hypoxia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Zev Rymer
investigator title: Research Scientist
mesh term: Spinal Cord Injuries
mesh term: Hypoxia
mesh term: Prednisolone
sharing ipd: No