<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/NCT04458324</url>
  </required_header>
  <id_info>
    <org_study_id>2020P001363</org_study_id>
    <nct_id>NCT04458324</nct_id>
  </id_info>
  <brief_title>Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury</brief_title>
  <official_title>Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a&#xD;
      unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical&#xD;
      Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg&#xD;
      exercise, resulting in the benefits of large muscle mass exercise. However, despite the&#xD;
      potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via&#xD;
      hybrid FES exercise, the inability to increase ventilation beyond limits set by high level&#xD;
      SCI restricts aerobic capacity.&#xD;
&#xD;
      This research study will investigate two potential methods of improving ventilation in those&#xD;
      with high-level SCI through a double-blind randomized trial. One method is non-invasive&#xD;
      ventilation (NIV), which is an external breathing support machine. The second method is the&#xD;
      use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats&#xD;
      and some human case reports.&#xD;
&#xD;
      In this study, participants will engage in a 6-month FES row training program while receiving&#xD;
      either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate&#xD;
      cardiopulmonary health and fitness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regular aerobic exercise with sufficient intensity can improve overall health, however daily&#xD;
      energy expenditure is low in those with SCI, especially in those with high level lesions. The&#xD;
      investigators have developed Functional Electrical Stimulation Row Training (FESRT) that&#xD;
      couples volitional arm and electrically controlled leg exercise, increasing the active muscle&#xD;
      and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing&#xD;
      aerobic capacity, those with high level lesions (T3 and above) have a remaining obstacle to&#xD;
      attaining higher work capacities: a level of pulmonary muscle denervation. The investigators&#xD;
      preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.&#xD;
&#xD;
      External ventilatory support could improve the ability to exercise train and hence enhance&#xD;
      the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during&#xD;
      exercise training has been shown to improve gains in exercise capacity in those with&#xD;
      similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV&#xD;
      during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic&#xD;
      capacity in high level SCI. In addition, pharmacologic treatments may augment respiratory&#xD;
      control and improve exercise ventilatory responses. Buspirone can reverse respiratory&#xD;
      abnormalities consequent to SCI in rats, and humans case reports suggest successful Buspirone&#xD;
      treatment of respiratory dysfunction&#xD;
&#xD;
      Therefore, the investigators propose a double-blind 2x2 trial of 6 months of FESRT with NIV&#xD;
      or Sham and Buspirone or Placebo in individuals with acute, high-level SCI. The investigators&#xD;
      hypothesize that both NIV and Buspirone will improve ventilatory exercise responses and that&#xD;
      combined treatment will have the greatest effect. This will result in greater improvements in&#xD;
      aerobic capacity and concomitant increases in pulmonary function and reductions in&#xD;
      cardiometabolic risk. This work proposes two approaches to overcome ventilatory limitations&#xD;
      to exercise in high level SCI and allow for greater improvements in cardiopulmonary capacity&#xD;
      - one that overcomes mechanical limitations of paralyzed pulmonary musculature and one that&#xD;
      treats loss of serotonergic respiratory control, both of which may contribute to blunted&#xD;
      ventilatory responses. The ultimate purpose of this research is to optimize exercise for a&#xD;
      population that both needs and seeks the broad range of benefits that exercise can confer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 22, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Subjects are assigned to one of four groups with equal chance: 1. NIV + Buspar, 2. NIV + placebo, 3. sham NIV + Buspar, or 4. sham NIV + placebo</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline aerobic exercise capacity</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline ventilation during exercise</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Participants perform incremental FES rowing exercise test to determine ventilation during exercise (VE peak).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucoregulatory status</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure the homeostasis model assessment (HOMA) of insulin resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucoregulatory status</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure the quantitative insulin check index (QUICKI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucoregulatory status</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure hemoglobin A1c.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in serum lipids</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure plasma total cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in serum lipids</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure low-density lipoprotein cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in serum lipids</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure high density apolipoprotein cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in serum lipids</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Blood will be taken via standard venipuncture to measure triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in visceral adiposity</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>The investigators will use a 5th generation General Electric Healthcare dual x-ray absorptiometry (DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline forced vital capacity</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Spirometry will be used to measure lung function, specifically forced vital capacity (FVC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline maximal voluntary ventilation</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Spirometry will be used to measure lung function, specifically maximal voluntary ventilation (MVV).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline forced expiratory capacity in the first second</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Spirometry will be used to measure lung function, specifically forced expiratory capacity in the first second (FEV1).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>NIV + Buspar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV + placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham NIV + Buspar</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham NIV + placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buspirone Hydrochloride</intervention_name>
    <description>Subjects take 30 mg buspirone HCl twice a day for 6 months.</description>
    <arm_group_label>NIV + Buspar</arm_group_label>
    <arm_group_label>sham NIV + Buspar</arm_group_label>
    <other_name>Buspar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buspirone placebo</intervention_name>
    <description>Subjects take a placebo tablet twice a day for 6 months.</description>
    <arm_group_label>NIV + placebo</arm_group_label>
    <arm_group_label>sham NIV + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive Ventilation (NIV)</intervention_name>
    <description>The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.</description>
    <arm_group_label>NIV + Buspar</arm_group_label>
    <arm_group_label>NIV + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Non-invasive ventilation (NIV)</intervention_name>
    <description>The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.</description>
    <arm_group_label>sham NIV + Buspar</arm_group_label>
    <arm_group_label>sham NIV + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Electrical Stimulation Row Training (FESRT)</intervention_name>
    <description>Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.</description>
    <arm_group_label>NIV + Buspar</arm_group_label>
    <arm_group_label>NIV + placebo</arm_group_label>
    <arm_group_label>sham NIV + Buspar</arm_group_label>
    <arm_group_label>sham NIV + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SCI outpatients aged 18-45 years&#xD;
&#xD;
          -  medically stable&#xD;
&#xD;
          -  body mass index 18.5-30 kg/m2 to include normal to overweight but not obese&#xD;
             individuals&#xD;
&#xD;
          -  3-months to 6-years post-injury&#xD;
&#xD;
          -  ASIA Scale A, B, or C injury at or above neurological level T4&#xD;
&#xD;
          -  able to follow directions&#xD;
&#xD;
          -  wheelchair users&#xD;
&#xD;
          -  leg muscles responsive to stimulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BP &gt;140/90 mmHg to exclude for hypertension (though rare in those with high level SCI)&#xD;
&#xD;
          -  current tobacco users&#xD;
&#xD;
          -  significant arrhythmias&#xD;
&#xD;
          -  coronary disease&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  renal disease&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  current use of cardioactive medications (except medication to support blood pressure)&#xD;
&#xD;
          -  current grade 2 or greater pressure ulcers at relevant contact sites&#xD;
&#xD;
          -  other neurological disease&#xD;
&#xD;
          -  peripheral nerve compressions or rotator cuff tears that limit the ability to row&#xD;
&#xD;
          -  history of bleeding disorders&#xD;
&#xD;
          -  current use of buspirone&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to&#xD;
             buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Glen Picard, MA</last_name>
    <phone>617-758-5511</phone>
    <email>gpicard@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Spaulding Hospital Cambridge</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Glen Picard, MA</last_name>
      <phone>617-758-5511</phone>
      <email>gpicard@partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>J. Andrew Taylor</investigator_full_name>
    <investigator_title>Director, Cardiovascular Research Lab</investigator_title>
  </responsible_party>
  <keyword>Function Electrical Stimulation (FES)-Rowing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buspirone</mesh_term>
  </intervention_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/NCT04458324
org study id: 2020P001363
nct id: NCT04458324
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a
      unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical
      Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg
      exercise, resulting in the benefits of large muscle mass exercise. However, despite the
      potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via
      hybrid FES exercise, the inability to increase ventilation beyond limits set by high level
      SCI restricts aerobic capacity.

      This research study will investigate two potential methods of improving ventilation in those
      with high-level SCI through a double-blind randomized trial. One method is non-invasive
      ventilation (NIV), which is an external breathing support machine. The second method is the
      use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats
      and some human case reports.

      In this study, participants will engage in a 6-month FES row training program while receiving
      either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate
      cardiopulmonary health and fitness.
Regular aerobic exercise with sufficient intensity can improve overall health, however daily
      energy expenditure is low in those with SCI, especially in those with high level lesions. The
      investigators have developed Functional Electrical Stimulation Row Training (FESRT) that
      couples volitional arm and electrically controlled leg exercise, increasing the active muscle
      and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing
      aerobic capacity, those with high level lesions (T3 and above) have a remaining obstacle to
      attaining higher work capacities: a level of pulmonary muscle denervation. The investigators
      preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT.

      External ventilatory support could improve the ability to exercise train and hence enhance
      the adaptations to chronic exercise in high level SCI. Non invasive ventilation (NIV) during
      exercise training has been shown to improve gains in exercise capacity in those with
      similarly restrictive breathing. Therefore, the investigators hypothesize that the use of NIV
      during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic
      capacity in high level SCI. In addition, pharmacologic treatments may augment respiratory
      control and improve exercise ventilatory responses. Buspirone can reverse respiratory
      abnormalities consequent to SCI in rats, and humans case reports suggest successful Buspirone
      treatment of respiratory dysfunction

      Therefore, the investigators propose a double-blind 2x2 trial of 6 months of FESRT with NIV
      or Sham and Buspirone or Placebo in individuals with acute, high-level SCI. The investigators
      hypothesize that both NIV and Buspirone will improve ventilatory exercise responses and that
      combined treatment will have the greatest effect. This will result in greater improvements in
      aerobic capacity and concomitant increases in pulmonary function and reductions in
      cardiometabolic risk. This work proposes two approaches to overcome ventilatory limitations
      to exercise in high level SCI and allow for greater improvements in cardiopulmonary capacity
      - one that overcomes mechanical limitations of paralyzed pulmonary musculature and one that
      treats loss of serotonergic respiratory control, both of which may contribute to blunted
      ventilatory responses. The ultimate purpose of this research is to optimize exercise for a
      population that both needs and seeks the broad range of benefits that exercise can confer.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Subjects are assigned to one of four groups with equal chance: 1. NIV + Buspar, 2. NIV + placebo, 3. sham NIV + Buspar, or 4. sham NIV + placebo
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in baseline aerobic exercise capacity
time frame: Baseline, 3 months, 6 months
description: Participants perform incremental FES rowing exercise test to determine maximum oxygen consumption (VO2 peak)
measure: Change in baseline ventilation during exercise
time frame: Baseline, 3 months, 6 months
description: Participants perform incremental FES rowing exercise test to determine ventilation during exercise (VE peak).
measure: Change from baseline in glucoregulatory status
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure the homeostasis model assessment (HOMA) of insulin resistance.
measure: Change from baseline in glucoregulatory status
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure the quantitative insulin check index (QUICKI).
measure: Change from baseline in glucoregulatory status
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure hemoglobin A1c.
measure: Change from baseline in serum lipids
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure plasma total cholesterol.
measure: Change from baseline in serum lipids
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure low-density lipoprotein cholesterol.
measure: Change from baseline in serum lipids
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure high density apolipoprotein cholesterol.
measure: Change from baseline in serum lipids
time frame: Baseline, 3 months, 6 months
description: Blood will be taken via standard venipuncture to measure triglycerides.
measure: Change from baseline in visceral adiposity
time frame: Baseline, 3 months, 6 months
description: The investigators will use a 5th generation General Electric Healthcare dual x-ray absorptiometry (DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.
measure: Change in baseline forced vital capacity
time frame: Baseline, 3 months, 6 months
description: Spirometry will be used to measure lung function, specifically forced vital capacity (FVC).
measure: Change in baseline maximal voluntary ventilation
time frame: Baseline, 3 months, 6 months
description: Spirometry will be used to measure lung function, specifically maximal voluntary ventilation (MVV).
measure: Change in baseline forced expiratory capacity in the first second
time frame: Baseline, 3 months, 6 months
description: Spirometry will be used to measure lung function, specifically forced expiratory capacity in the first second (FEV1).
arm group label: NIV + Buspar
arm group type: Experimental
description: Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar.
arm group label: NIV + placebo
arm group type: Placebo Comparator
description: Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo.
arm group label: sham NIV + Buspar
arm group type: Sham Comparator
description: Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar.
arm group label: sham NIV + placebo
arm group type: Active Comparator
description: Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo.
intervention type: Drug
intervention name: Buspirone Hydrochloride
description: Subjects take 30 mg buspirone HCl twice a day for 6 months.
arm group label: NIV + Buspar
arm group label: sham NIV + Buspar
other name: Buspar
intervention type: Drug
intervention name: Buspirone placebo
description: Subjects take a placebo tablet twice a day for 6 months.
arm group label: NIV + placebo
arm group label: sham NIV + placebo
intervention type: Device
intervention name: Noninvasive Ventilation (NIV)
description: The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
arm group label: NIV + Buspar
arm group label: NIV + placebo
intervention type: Device
intervention name: Sham Non-invasive ventilation (NIV)
description: The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
arm group label: sham NIV + Buspar
arm group label: sham NIV + placebo
intervention type: Other
intervention name: Functional Electrical Stimulation Row Training (FESRT)
description: Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
arm group label: NIV + Buspar
arm group label: NIV + placebo
arm group label: sham NIV + Buspar
arm group label: sham NIV + placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Glen Picard, MA
phone: 617-758-5511
email: gpicard@partners.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: J. Andrew Taylor
investigator title: Director, Cardiovascular Research Lab
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Buspirone