<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/NCT04430218</url>
  </required_header>
  <id_info>
    <org_study_id>A3355-R</org_study_id>
    <secondary_id>RX003355-01</secondary_id>
    <nct_id>NCT04430218</nct_id>
  </id_info>
  <brief_title>Peripheral Interfaces in Amputees for Sensorimotor Integration</brief_title>
  <acronym>iSens</acronym>
  <official_title>Peripheral Interfaces in Amputees for Sensorimotor Integration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Defense Advanced Research Projects Agency</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to gather information on the safety and effectiveness of an&#xD;
      implanted wireless sensory enabled highly intuitive controlled prosthetic device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves a surgical implant of cuff electrodes on the residual nerves in the&#xD;
      amputated limb, and muscle recording electrodes in muscles. These will be connected to an&#xD;
      implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This&#xD;
      may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is&#xD;
      touching.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2032</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>
    <intervention_model_description>This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessments will be analyzed by a blinded assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Experience Measure</measure>
    <time_frame>9 months post implant</time_frame>
    <description>Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Box and Blocks</measure>
    <time_frame>9 months post implant</time_frame>
    <description>Measuring the change in numbers of blocks moved during a timed test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Upper Extremity Amputee</condition>
  <arm_group>
    <arm_group_label>iSens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 months trial with the iSens system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>State of the Art Prosthesis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3 months trial with their own prosthesis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iSens</intervention_name>
    <description>The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.</description>
    <arm_group_label>iSens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or greater&#xD;
&#xD;
          -  Acquired upper limb amputation&#xD;
&#xD;
          -  Unilateral or bilateral amputation, Above or below elbow&#xD;
&#xD;
          -  At least 6 months since time of amputation&#xD;
&#xD;
          -  Current user of a myoelectric prosthesis or prescribed to use one&#xD;
&#xD;
          -  Viable target nerves in the upper extremity *&#xD;
&#xD;
          -  Recommendation from a psychologist following a psychological assessment that the&#xD;
             subject is mentally competent and capable of completing the study related activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A contraindication preventing surgery&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Chronic skin ulcerations&#xD;
&#xD;
          -  History of poor wound healing without specific cause&#xD;
&#xD;
          -  History of uncontrolled infection without specific cause&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Pregnancy or women of childbearing potential unwilling to prevent pregnancy during&#xD;
             participation in the study&#xD;
&#xD;
          -  Inability to speak English&#xD;
&#xD;
          -  Expectation that MRI will be required at any point for duration of study or while&#xD;
             device is implanted.&#xD;
&#xD;
          -  Arthritis in the area of implant&#xD;
&#xD;
          -  Individuals with active implantable medical devices or individuals that use external&#xD;
             active medical devices that are medically necessary and/or life-supporting or&#xD;
             life-sustaining (e.g. insulin pumps, ventilators)&#xD;
&#xD;
          -  Presence of auto immune diseases, or conditions requiring immunosuppression.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dustin J. Tyler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louis Stokes VA Medical Center, Cleveland, OH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dustin J Tyler, PhD</last_name>
    <phone>(216) 791-3800</phone>
    <email>Dustin.Tyler@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Melissa S Schmitt</last_name>
    <phone>(216) 791-3800</phone>
    <phone_ext>63801</phone_ext>
    <email>Melissa.Schmitt@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Louis Stokes VA Medical Center, Cleveland, OH</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-1702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Holly B Henry</last_name>
      <phone>216-791-3800</phone>
      <phone_ext>64657</phone_ext>
      <email>holly.henry@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Neal S Peachey, PhD</last_name>
      <phone>(216) 421-3221</phone>
      <email>neal.peachey@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Dustin J. Tyler, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sensory Feedback</keyword>
  <keyword>Advanced Control</keyword>
  <keyword>Sensorimotor feedback</keyword>
  <keyword>Prostheses and implants</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Deidentified data will be uploaded to a data repository.</ipd_description>
  </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/NCT04430218
org study id: A3355-R
secondary id: RX003355-01
nct id: NCT04430218
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this research is to gather information on the safety and effectiveness of an
      implanted wireless sensory enabled highly intuitive controlled prosthetic device.
The study involves a surgical implant of cuff electrodes on the residual nerves in the
      amputated limb, and muscle recording electrodes in muscles. These will be connected to an
      implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This
      may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is
      touching.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The assessments will be analyzed by a blinded assessor.
measure: Patient Experience Measure
time frame: 9 months post implant
description: Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.
measure: Modified Box and Blocks
time frame: 9 months post implant
description: Measuring the change in numbers of blocks moved during a timed test.
arm group label: iSens
arm group type: Experimental
description: 3 months trial with the iSens system
arm group label: State of the Art Prosthesis
arm group type: No Intervention
description: 3 months trial with their own prosthesis.
intervention type: Device
intervention name: iSens
description: The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
arm group label: iSens
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Dustin J. Tyler, PhD
role: Principal Investigator
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
last name: Dustin J Tyler, PhD
phone: (216) 791-3800
email: Dustin.Tyler@va.gov
last name: Melissa S Schmitt
phone: (216) 791-3800
phone ext: 63801
email: Melissa.Schmitt@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Deidentified data will be uploaded to a data repository.