<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/NCT03259386</url>
  </required_header>
  <id_info>
    <org_study_id>14-007456</org_study_id>
    <secondary_id>W81XWH-13-PRORP-TRA</secondary_id>
    <nct_id>NCT03259386</nct_id>
  </id_info>
  <brief_title>Movement and Sensation for Advanced Prosthetic Hands</brief_title>
  <official_title>Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dexterous Control of, and Modulated Sensory Feedback From, a Hand Prosthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <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 study is to learn more information about nerves. This study is also&#xD;
      designed to learn how the information in nerves could be used to develop new prosthetic&#xD;
      devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The general design of the study is broken down into two parts: the pre- and post-implantation&#xD;
      schedules:&#xD;
&#xD;
      During the 30 days before implantation the participant will be asked to take home a small&#xD;
      computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be&#xD;
      asked to use these items five (5) times a week for 30 minutes a session and interact with a&#xD;
      displayed virtual reality environment. In this environment the participant will move their&#xD;
      intact hand and the Leap Motion will display the hand movements in the virtual environment&#xD;
      with the intact hand movements being mirrored between two hand facsimile. The participant&#xD;
      will be instructed to move and stretch both their phantom and intact hand in a mirrored&#xD;
      fashion. The purpose of these exercises are to allow the participant to become accustomed to&#xD;
      the virtual reality setup (equipment and display) as well as providing a mirror box like&#xD;
      effect where the virtual hand facsimile for their phantom hand is mapped to their body.&#xD;
&#xD;
      The second phase of the general design continues for 30-90 days post-implantation. We shall&#xD;
      perform electrophysiological recordings from a single microelectrode array implanted into&#xD;
      either the median, radial, or ulnar nerve. Neural signals (single and compound action&#xD;
      potentials) evoked by variegated movements of the fingers and thumb will be recorded on the&#xD;
      implanted microelectrode array. By recording electrical signals from the nerves the&#xD;
      investigators hope to decode finger movements in real-time using machine learning algorithms.&#xD;
      The participants will be asked to complete tasks in controlled virtual environment during the&#xD;
      training phase. The virtual environment, which includes virtual arms and hands, will be&#xD;
      presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task&#xD;
      will require recording the position of arms in space which will be accomplished using the&#xD;
      Vicon motion capture system that will use infra-red reflecting markers attached to the&#xD;
      participant's arms. The investigators will also use a marker-less motion capture system, Leap&#xD;
      Motion, to track the specific movements of the intact hand. Post training, the investigators&#xD;
      aim to perform real-time decoding of finger movements in the virtual reality environments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Problem with obtaining microarrays, which are essential components needed to conduct this&#xD;
    study.&#xD;
  </why_stopped>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">October 24, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects for whom the investigators can decode finger movements</measure>
    <time_frame>From 44-104 days post-implantation</time_frame>
    <description>High-count microelectrode arrays are implanted into upper limb peripheral nerves of transradial and transhumeral amputees. Direct micro-stimulation of peripheral nerves will be done using the microelectrode array.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Transradial or Transhumeral amputees</arm_group_label>
    <description>High-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microelectrode array</intervention_name>
    <description>Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.</description>
    <arm_group_label>Transradial or Transhumeral amputees</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        These are patients that have previously undergone a transradial or transhumeral amputation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patient has previously undergone a transradial (below elbow) or transhumeral (above&#xD;
        elbow) amputation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Incarceration&#xD;
&#xD;
          3. Inability to consent&#xD;
&#xD;
          4. Serious, untreated comorbidity&#xD;
&#xD;
          5. Patient is diagnosed with a medical condition(s) that seriously increase the risk of&#xD;
             electrode implantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shelley Noland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Shelley S. Noland</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03259386
org study id: 14-007456
secondary id: W81XWH-13-PRORP-TRA
nct id: NCT03259386
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to learn more information about nerves. This study is also
      designed to learn how the information in nerves could be used to develop new prosthetic
      devices.
The general design of the study is broken down into two parts: the pre- and post-implantation
      schedules:

      During the 30 days before implantation the participant will be asked to take home a small
      computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be
      asked to use these items five (5) times a week for 30 minutes a session and interact with a
      displayed virtual reality environment. In this environment the participant will move their
      intact hand and the Leap Motion will display the hand movements in the virtual environment
      with the intact hand movements being mirrored between two hand facsimile. The participant
      will be instructed to move and stretch both their phantom and intact hand in a mirrored
      fashion. The purpose of these exercises are to allow the participant to become accustomed to
      the virtual reality setup (equipment and display) as well as providing a mirror box like
      effect where the virtual hand facsimile for their phantom hand is mapped to their body.

      The second phase of the general design continues for 30-90 days post-implantation. We shall
      perform electrophysiological recordings from a single microelectrode array implanted into
      either the median, radial, or ulnar nerve. Neural signals (single and compound action
      potentials) evoked by variegated movements of the fingers and thumb will be recorded on the
      implanted microelectrode array. By recording electrical signals from the nerves the
      investigators hope to decode finger movements in real-time using machine learning algorithms.
      The participants will be asked to complete tasks in controlled virtual environment during the
      training phase. The virtual environment, which includes virtual arms and hands, will be
      presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task
      will require recording the position of arms in space which will be accomplished using the
      Vicon motion capture system that will use infra-red reflecting markers attached to the
      participant's arms. The investigators will also use a marker-less motion capture system, Leap
      Motion, to track the specific movements of the intact hand. Post training, the investigators
      aim to perform real-time decoding of finger movements in the virtual reality environments.
observational model: Cohort
time perspective: Prospective
measure: Number of subjects for whom the investigators can decode finger movements
time frame: From 44-104 days post-implantation
description: High-count microelectrode arrays are implanted into upper limb peripheral nerves of transradial and transhumeral amputees. Direct micro-stimulation of peripheral nerves will be done using the microelectrode array.
arm group label: Transradial or Transhumeral amputees
description: High-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees.
intervention type: Device
intervention name: Microelectrode array
description: Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.
arm group label: Transradial or Transhumeral amputees
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shelley Noland, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Shelley S. Noland
investigator title: Principal Investigator