<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/NCT04490382</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00102757</org_study_id>
    <nct_id>NCT04490382</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation (SCS) for Amputees</brief_title>
  <official_title>Evaluate Tactile Sensation and Proprioception in Lower Limb Amputees Using Neuromodulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</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 investigate how leg amputee patients can feel sensations with&#xD;
      neuromodulation while they are using a prosthetic leg. &quot;Neuromodulation&quot; is the process by&#xD;
      which the nervous system can be regulated by targeted delivery of a stimulus, such as&#xD;
      electrical stimulation or chemical agents, to specific neurological sites in the body. In&#xD;
      this study, the investigators plan to use either electrical stimulation of the spinal cord&#xD;
      (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG&#xD;
      stimulation) as methods for neuromodulation.&#xD;
&#xD;
      Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at&#xD;
      Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four&#xD;
      times during the two weeks following the implantation of trial stimulation leads to evaluate&#xD;
      sensations related to touch and position of the prosthetic leg as they are generated by&#xD;
      neuromodulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 20, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in stimulation as reported by patients</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stimulation parameters as measured by frequency</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stimulation parameters as measured by pulse width</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in stimulation parameters as measured by amplitude</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain score as measured by McGill Pain Questionnaire</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in gait parameters as measured by step frequency</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in passive movement detection as measured by external sensors</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cortical reorganization measured by Electroencephalogram (EEG)</measure>
    <time_frame>Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Somatosensory Perception Following Lower Limb Amputation</condition>
  <arm_group>
    <arm_group_label>Patients undergoing Neuromodulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>32 channel external stimulator</intervention_name>
    <description>Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.</description>
    <arm_group_label>Patients undergoing Neuromodulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 18 years of age&#xD;
&#xD;
          -  Subject is able and willing to comply with the schedule and protocol&#xD;
&#xD;
          -  Subject is a lower limb amputee who uses a prosthetic leg&#xD;
&#xD;
          -  Subject is a good candidate for implantation of a stimulator for their amputation&#xD;
             related pain&#xD;
&#xD;
          -  Subject has stable neurological/cognitive function in the past 30 days&#xD;
&#xD;
          -  Subject is able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is currently participating in a clinical investigation that includes an active&#xD;
             treatment arm&#xD;
&#xD;
          -  Subject currently has an active implantable device including an Implantable&#xD;
             Cardioverter Defibrillator (ICD), pacemaker, spinal cord stimulator, or intrathecal&#xD;
             drug pump&#xD;
&#xD;
          -  Subject is a prisoner&#xD;
&#xD;
          -  Female subject whom are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nandan Lad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuromodulation</keyword>
  <keyword>Phantom pain</keyword>
  <keyword>Amputation</keyword>
  <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/NCT04490382
org study id: Pro00102757
nct id: NCT04490382
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to investigate how leg amputee patients can feel sensations with
      neuromodulation while they are using a prosthetic leg. "Neuromodulation" is the process by
      which the nervous system can be regulated by targeted delivery of a stimulus, such as
      electrical stimulation or chemical agents, to specific neurological sites in the body. In
      this study, the investigators plan to use either electrical stimulation of the spinal cord
      (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG
      stimulation) as methods for neuromodulation.

      Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at
      Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four
      times during the two weeks following the implantation of trial stimulation leads to evaluate
      sensations related to touch and position of the prosthetic leg as they are generated by
      neuromodulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in stimulation as reported by patients
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by frequency
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by pulse width
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in stimulation parameters as measured by amplitude
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in pain score as measured by McGill Pain Questionnaire
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in gait parameters as measured by step frequency
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in passive movement detection as measured by external sensors
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
measure: Change in cortical reorganization measured by Electroencephalogram (EEG)
time frame: Visit 1(baseline), visit 2(up to six hours), visit 3(up to six hours), visit 4(up to six hours)
arm group label: Patients undergoing Neuromodulation
arm group type: Experimental
description: Patients, who have had a lower limb amputation and undergoing neuromodulation as part of standard of care.
intervention type: Device
intervention name: 32 channel external stimulator
description: Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.
arm group label: Patients undergoing Neuromodulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nandan Lad, MD
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
sharing ipd: No