<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/NCT03774043</url>
  </required_header>
  <id_info>
    <org_study_id>STU00202027</org_study_id>
    <nct_id>NCT03774043</nct_id>
  </id_info>
  <brief_title>Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI</brief_title>
  <official_title>Timing and Dosage Parameters of Acute Intermittent Hypoxia in Individuals With Spinal Cord Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <brief_summary>
    <textblock>
      This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce&#xD;
      spinal plasticity while evaluating the appropriate timing schedule for this intervention, as&#xD;
      well as, the effects of superimposing sessions of a therapy, in individuals with chronic&#xD;
      incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay&#xD;
      following a single session or multiple sessions of AIH therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in grip strength</measure>
    <time_frame>Baseline, immediately following intervention, and every 30 minutes for 5 hours</time_frame>
    <description>A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pinch Strength</measure>
    <time_frame>Baseline, immediately following intervention, and every 30 minutes for 5 hours</time_frame>
    <description>A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9 Hole Peg Test</measure>
    <time_frame>Baseline, immediately following intervention, and every 30 minutes for 5 hours</time_frame>
    <description>A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Box and Blocks test</measure>
    <time_frame>Baseline, immediately following intervention, and every 30 minutes for 5 hours</time_frame>
    <description>A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Single session of Acute Intermittent Hypoxia (AIH)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Single session of Sham Acute Intermittent Hypoxia (Sham AIH)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Two successive sessions of AIH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Two successive sessions of Sham AIH</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acute Intermittent Hypoxia</intervention_name>
    <description>Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.</description>
    <arm_group_label>Single session of Acute Intermittent Hypoxia (AIH)</arm_group_label>
    <arm_group_label>Two successive sessions of AIH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Acute Intermittent Hypoxia</intervention_name>
    <description>Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.</description>
    <arm_group_label>Single session of Sham Acute Intermittent Hypoxia (Sham AIH)</arm_group_label>
    <arm_group_label>Two successive sessions of Sham AIH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Spinal cord lesion at level of C3 to T1&#xD;
&#xD;
          2. Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D&#xD;
&#xD;
          3. Individuals must be at least 6 months status post injury&#xD;
&#xD;
          4. Individuals must be between the ages of 18-70 years inclusive, male or female&#xD;
&#xD;
          5. Spinal cord injury must be secondary to a non-progressive etiology&#xD;
&#xD;
          6. Individuals must be medically stable.&#xD;
&#xD;
          7. Able to comply with protocol/study requirements&#xD;
&#xD;
          8. Not currently (&gt;2 weeks) taking any medications for spasticity management.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recent change in the use of narcotic, anti-inflammatory or pain medication&#xD;
&#xD;
          2. Unstable medical conditions or any other clinical observation that may affect the&#xD;
             candidate's performance, health, safety or the ability to participate in the study, as&#xD;
             determined by the treating therapist&#xD;
&#xD;
          3. History of sleep apnea&#xD;
&#xD;
          4. Active participation in another movement research study or therapy program&#xD;
&#xD;
          5. Anti-spasticity drug injection less than 3 months, prior to beginning treatment&#xD;
&#xD;
          6. Musculoskeletal pain that interferes with participation in study&#xD;
&#xD;
          7. Women who are currently, may be or planning on becoming pregnant&#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_contact>
    <last_name>Milap Sandhu, PT, PhD</last_name>
    <phone>3122386529</phone>
    <email>m-sandhu@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sofia Anastasopoulos</last_name>
    <email>sanastasop@ric.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milap S Sandhu, PT, PhD</last_name>
      <phone>312-238-6529</phone>
      <email>m-sandhu@northwestern.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>February 17, 2020</last_update_submitted>
  <last_update_submitted_qc>February 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Milap Sandhu</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <!-- 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/NCT03774043
org study id: STU00202027
nct id: NCT03774043
lead sponsor: 
This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce
      spinal plasticity while evaluating the appropriate timing schedule for this intervention, as
      well as, the effects of superimposing sessions of a therapy, in individuals with chronic
      incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay
      following a single session or multiple sessions of AIH therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in grip strength
time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
description: A dynamometer measures maximum gross grasp (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg lb will be assigned when the participant cannot actively flex the fingers or grasp the dynamometer. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The forearm should be in neutral rotation. The arm should not be supported by an arm rest or research personnel.
measure: Pinch Strength
time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
description: A pinch gauge measures maximum pinch force (kglb) averaged over three attempts with each hand. The minimum possible value of zero kg will be assigned when the participant cannot actively squeeze the pinch meter between the thumb and index finger. Standard position includes the participant in a supported sitting position, with shoulder in adducted and in neutral rotation and the elbow flexed at 90 degrees. The gauge will be placed between the thumb and lateral surface of the index finger (lateral pinch).
measure: 9 Hole Peg Test
time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
description: A measure of finger dexterity involving the placement of pegs from a container to holes on a board, and subsequent removal, as quickly as possible. The total number of seconds until task completion is recorded, as measured by when the participant touches the first peg to when the last peg is placed back into the container.
measure: Box and Blocks test
time frame: Baseline, immediately following intervention, and every 30 minutes for 5 hours
description: A measure of manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds
arm group label: Single session of Acute Intermittent Hypoxia (AIH)
arm group type: Experimental
arm group label: Single session of Sham Acute Intermittent Hypoxia (Sham AIH)
arm group type: Placebo Comparator
arm group label: Two successive sessions of AIH
arm group type: Experimental
arm group label: Two successive sessions of Sham AIH
arm group type: Placebo Comparator
intervention type: Other
intervention name: Acute Intermittent Hypoxia
description: Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.
arm group label: Single session of Acute Intermittent Hypoxia (AIH)
arm group label: Two successive sessions of AIH
intervention type: Other
intervention name: Sham Acute Intermittent Hypoxia
description: Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.
arm group label: Single session of Sham Acute Intermittent Hypoxia (Sham AIH)
arm group label: Two successive sessions of Sham AIH
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Milap Sandhu, PT, PhD
phone: 3122386529
email: m-sandhu@northwestern.edu
last name: Sofia Anastasopoulos
email: sanastasop@ric.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Milap Sandhu
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries
mesh term: Hypoxia