<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/NCT03783689</url>
  </required_header>
  <id_info>
    <org_study_id>0147-CSP-000</org_study_id>
    <nct_id>NCT03783689</nct_id>
  </id_info>
  <brief_title>The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain</brief_title>
  <acronym>SNAP</acronym>
  <official_title>The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain in a Randomized, Double-blinded, Placebo-controlled, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SPR Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SPR Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      The purpose of this study is to determine if pain can be relieved by delivering small amounts&#xD;
      of electricity (called &quot;electrical stimulation&quot;) to the nerves in an individual's amputated&#xD;
      leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is&#xD;
      made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA&#xD;
      for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">September 22, 2022</completion_date>
  <primary_completion_date type="Actual">September 22, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])</measure>
    <time_frame>Baseline, 5-weeks post-Start of Therapy (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT</time_frame>
    <description>Measured using question 5 from the Brief Pain Inventory- Short Form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>During Lead placement at Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>24-48 hours post-Lead placement</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>1-week post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>2-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>3-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>4-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>5-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>6-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>7-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>8-weeks post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>1-week post-Lead removal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>3-months post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>6-months post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>9-months post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>12-months post-Start of Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>During Lead placement at Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>2-weeks post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>4-weeks post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>8-weeks post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>3-months post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>6-months post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>9-months post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study-Related Adverse Device Effects</measure>
    <time_frame>12-months post-Start of optional Crossover Treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT</time_frame>
    <description>Measured using question 9 of the Brief Pain Inventory- Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Disability</measure>
    <time_frame>Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT</time_frame>
    <description>Measured using the Pain Disability Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT</time_frame>
    <description>Measured using the Patient Global Impression of Change PGIC survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Baseline, 4-weeks post-Start of Treatment (SOT), and 8-weeks post-SOT</time_frame>
    <description>The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents &quot;not at all,&quot; and 4 represents &quot;all the time.&quot; The scores from each question are summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores are then calculated across all subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Medication Usage</measure>
    <time_frame>Weeks 1-4 post-Start of Treatment (SOT), weeks 5-8 post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])</measure>
    <time_frame>1-week post-Start of Treatment (SOT), 2-weeks post-SOT, 3-weeks post-SOT, and 4-weeks post-SOT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with ≥50% reduction in average Residual limb pain (RLP)</measure>
    <time_frame>5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with ≥50% reduction in average phantom limb pain (PLP)</measure>
    <time_frame>5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of Treatment Effect on Average Pain Intensity</measure>
    <time_frame>3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Neuropathic Pain</condition>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Group 1 (Treatment)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in Group 1 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Control)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects in Group 2 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Subjects will then have the option to crossover and receive stimulation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPRINT Peripheral Nerve Stimulation (PNS) System</intervention_name>
    <description>The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called &quot;Leads&quot;) that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).</description>
    <arm_group_label>Group 1 (Treatment)</arm_group_label>
    <arm_group_label>Group 2 (Control)</arm_group_label>
    <other_name>SPRINT</other_name>
    <other_name>SPRINT System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  At least 21 years old&#xD;
&#xD;
          -  Lower extremity amputation&#xD;
&#xD;
          -  Experiencing residual limb (stump) and/or phantom limb pain&#xD;
&#xD;
          -  Healed amputation and healthy residual limb based upon the investigator's evaluation&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Conditions with increased risk of infection (e.g., compromised immune system or&#xD;
             history of recurrent skin infections)&#xD;
&#xD;
          -  Implanted electronic device&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pain Center of Arizona - Hope Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Nona Medical Arts</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James A. Haley Veterans' Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health Clinical Research</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuroscience Research Center, LLC</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OtriMed Clinical Research Center</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedVadis Research</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Pain Centers</name>
      <address>
        <city>Shrewsbury</city>
        <state>New Jersey</state>
        <zip>07702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pain Management Center</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</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>Neuralgia</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/NCT03783689
org study id: 0147-CSP-000
nct id: NCT03783689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine if pain can be relieved by delivering small amounts
      of electricity (called "electrical stimulation") to the nerves in an individual's amputated
      leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is
      made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA
      for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])
time frame: Baseline, 5-weeks post-Start of Therapy (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT
description: Measured using question 5 from the Brief Pain Inventory- Short Form
measure: Study-Related Adverse Device Effects
time frame: During Lead placement at Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 24-48 hours post-Lead placement
measure: Study-Related Adverse Device Effects
time frame: 1-week post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 2-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 3-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 4-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 5-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 6-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 7-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 8-weeks post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 1-week post-Lead removal
measure: Study-Related Adverse Device Effects
time frame: 3-months post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 6-months post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 9-months post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: 12-months post-Start of Treatment
measure: Study-Related Adverse Device Effects
time frame: During Lead placement at Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 2-weeks post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 4-weeks post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 8-weeks post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 3-months post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 6-months post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 9-months post-Start of optional Crossover Treatment
measure: Study-Related Adverse Device Effects
time frame: 12-months post-Start of optional Crossover Treatment
measure: Pain Interference
time frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT
description: Measured using question 9 of the Brief Pain Inventory- Short Form
measure: Pain Disability
time frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT
description: Measured using the Pain Disability Index
measure: Patient Global Impression of Change (PGIC)
time frame: Baseline, 4-weeks post-Start of Therapy (SOT), 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT
description: Measured using the Patient Global Impression of Change PGIC survey
measure: Pain Catastrophizing Scale (PCS)
time frame: Baseline, 4-weeks post-Start of Treatment (SOT), and 8-weeks post-SOT
description: The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question are summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores are then calculated across all subjects.
measure: Pain Medication Usage
time frame: Weeks 1-4 post-Start of Treatment (SOT), weeks 5-8 post-SOT, 3-months post-SOT, 6-months post-SOT, and 12-months post-SOT
measure: Proportion of subjects with ≥50% reduction in average post-amputation pain (residual limb pain [RLP] and/or phantom limb pain [PLP])
time frame: 1-week post-Start of Treatment (SOT), 2-weeks post-SOT, 3-weeks post-SOT, and 4-weeks post-SOT
measure: Proportion of subjects with ≥50% reduction in average Residual limb pain (RLP)
time frame: 5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT
measure: Proportion of subjects with ≥50% reduction in average phantom limb pain (PLP)
time frame: 5-weeks post-Start of Treatment (SOT), 6-weeks post-SOT, 7-weeks post-SOT, and 8-weeks post-SOT
measure: Durability of Treatment Effect on Average Pain Intensity
time frame: 3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT
arm group label: Group 1 (Treatment)
arm group type: Active Comparator
description: Subjects in Group 1 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
arm group label: Group 2 (Control)
arm group type: Sham Comparator
description: Subjects in Group 2 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Subjects will then have the option to crossover and receive stimulation therapy.
intervention type: Device
intervention name: SPRINT Peripheral Nerve Stimulation (PNS) System
description: The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
arm group label: Group 1 (Treatment)
arm group label: Group 2 (Control)
other name: SPRINT
other name: SPRINT System
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuralgia