xml: <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/NCT05994846</url>
    </required_header>
    <id_info>
      <org_study_id>Rises-T 2.0 iRISID-2023-2024</org_study_id>
      <nct_id>NCT05994846</nct_id>
    </id_info>
    <brief_title>Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal</brief_title>
    <acronym>RISES-T2</acronym>
    <official_title>The Reynolds Innovative Spinal Electrical Stimulation Program: Transcutaneous Stimulation (RISES-T 2.0)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tim Reynolds</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Thomas Jefferson 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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objectives of this study are to (1) determine the effects of neuromodulation techniques&#xD;
        on mobility in persons with chronic SCI, as measured by subjective and objective measures,&#xD;
        and (2) to determine the optimal combination of techniques that modify mobility and movement&#xD;
        in an individual. The neuromodulation techniques explored will be methods of electromagnetic&#xD;
        stimulation - that is, electrical stimulation and magnetic stimulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is designed in two Parts. Part 1 of the study will collect information about the&#xD;
        participant's baseline mobility and muscular activation potential. The information collected&#xD;
        in these sessions will, in effect, assess the participant's eligibility to continue in the&#xD;
        study and move onto Part 2.&#xD;
  &#xD;
        Part 1- Assessment Sessions This part of the study designed to determine (1) which, if any,&#xD;
        of the participant's muscles respond to stimulation and, if there are responses observed, (2)&#xD;
        what stimulation parameters and modalities would be best suited for the participant during&#xD;
        Part 2 of the trial. The team will create a participant-specific menu of modalities and&#xD;
        pre-defined parameters for electromagnetic stimulation (e.g., amplitude, channels,&#xD;
        frequencies, electrode placement, etc.) from which they will select for participant visits in&#xD;
        Part 2 of the study. They will also capture the participant's Movement Signature (the pattern&#xD;
        of movement as measured by accelerometers and surface EMG that a person exhibits while&#xD;
        sitting/standing at rest and/or doing specific tasks to inform Part 2 of the study. Finally,&#xD;
        the participants will complete a Baseline Clinical Outcome Measures validated for SCI to&#xD;
        provide baseline data prior to the neuromodulation intervention.&#xD;
  &#xD;
        Part 2 - The Experimental Cycles This part of the study will consist of Intervention&#xD;
        Sessions, in which the team will apply transcutaneous stimulation to the participant's target&#xD;
        muscles identified in Part 1, using the parameters and modalities deemed best suited for the&#xD;
        participant. during tasks and activities deemed most appropriate for the targeted muscles.&#xD;
        The team will measure the effects of electromagnetic stimulation on the participant's muscle&#xD;
        activity and movement.&#xD;
  &#xD;
        The Cycle will also include Biometric sessions, where the participant will engage in a series&#xD;
        of upper extremity, trunk and/or lower extremity repetitive tasks from their prescribed&#xD;
        &quot;activity library&quot; that was created for them during Part 1 of the study and the team will&#xD;
        measure changes in muscle tone, strength, and movement before and after stimulation. In other&#xD;
        sessions, the participant will undergo a series of more targeted tasks with and without&#xD;
        electromagnetic stimulation applied, to measure changes in the participant's neurophysiology,&#xD;
        kinetics, and kinematics due to electromagnetic stimulation.&#xD;
  &#xD;
        After a series of Intervention and Biometrics Sessions, if there are no changes observed in&#xD;
        the participant's kinematics or EMG signals in the and/or in select outcome measures, the&#xD;
        participant will enter a Parameter Optimization Session. During this session, the study team&#xD;
        will revisit the library of stimulation parameters that were defined for the participant&#xD;
        during Part 1 of the study and refine the parameters for use in the next Experimental Cycle.&#xD;
        The manipulation and refinement of these parameters will be done with the aim of achieving&#xD;
        changes in the subsequent Experimental Cycle.&#xD;
  &#xD;
        The participant will continue in the study until the time that there is no observed effect of&#xD;
        stimulation for three (3) consecutive Experimental Cycles, or may continue for a maximum of&#xD;
        six (6) Experimental Cycles. At the end of the study, the participant will repeat the series&#xD;
        of Clinical Outcome Measures that were completed at Baseline.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 23, 2023</start_date>
    <completion_date type="Anticipated">June 23, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 23, 2025</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>
      <intervention_model_description>Prospective, unblinded, feasibility study where participants will serve as their own controls.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Spinal Cord Injury-Motor Index (SCI MovIN)</measure>
      <time_frame>Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks</time_frame>
      <description>evaluates movement, and recovery of neurotypical movement, within a functional context that accounts for compensations and disallows substitutions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks</time_frame>
      <description>measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual Muscle Testing (MMT)</measure>
      <time_frame>Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks</time_frame>
      <description>standardized set of assessments that measure muscle strength and function</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Capabilities of Upper Extremity Test (CUE-T)</measure>
      <time_frame>Once at 2 weeks after consent, and once within 9-24 weeks after consent</time_frame>
      <description>A performance measure intended to assess upper extremity function following spinal cord injury (SCI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)</measure>
      <time_frame>Once at 2 weeks after consent, and once within 9-24 weeks after consent</time_frame>
      <description>A patient self-reported measure of consequences of pain on aspects of their life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Walking Index for SCI (WISCI-II)</measure>
      <time_frame>Once at 2 weeks after consent, and once within 9-24 weeks after consent</time_frame>
      <description>A measure of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numeric Pain Rating Scale (NPRS)</measure>
      <time_frame>Once at 2 weeks after consent, and once within 9-24 weeks after consent</time_frame>
      <description>The patient reported outcome measure the subjective intensity of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change (PGIC) Questionnaires (bowel program, bladder function, dysreflexia, pain, sensation)</measure>
      <time_frame>Once at 2 weeks after consent, and once within 9-24 weeks after consent</time_frame>
      <description>Questionnaires to assess the status of or changes in bladder function, bowel regimen, dysreflexia, pain and sensation.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Spinal Cord Diseases</condition>
    <arm_group>
      <arm_group_label>Experimental Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RISES-T System</intervention_name>
      <description>The RISES-T system is a hardware and software platform that has been designed and developed to help people living with movement impairment due to Spinal Cord Injury (SCI) to improve and/or restore mobility. The hardware consists of a functional electrical stimulation device that delivers stimulation to the skin through surface electrodes; a series of wearable sensors that collect kinematic (IMU) data and muscle activity (EMG) data, and RISES Software, which incorporates algorithms that utilizes the streaming IMU and EMG sensor data to inform the electrical stimulation parameters and enables real-time visualization of the sensor data and stimulation parameters via Graphical User Interface (GUI).</description>
      <arm_group_label>Experimental Treatment Arm</arm_group_label>
      <other_name>Trancutaneous spinal stimulation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Has a non-progressive or central cord spinal cord injury&#xD;
  &#xD;
          American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or&#xD;
          D&#xD;
  &#xD;
          Can participate in physical and occupational therapy rehabilitation programs&#xD;
  &#xD;
          Is at minimum 12 months post-injury&#xD;
  &#xD;
          Can provide informed consent&#xD;
  &#xD;
          Has adequate caregiver support to facilitate participation in study&#xD;
  &#xD;
          Is willing to undergo audio-visual recording sessions&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by&#xD;
          investigators)&#xD;
  &#xD;
          Has any unstable or significant medical condition that is likely to interfere with study&#xD;
          procedures or likely to confound study endpoint evaluations like severe neuropathic pain,&#xD;
          depression, mood disorders or other cognitive disorders&#xD;
  &#xD;
          Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled&#xD;
          orthostatic hypotension that may interfere with rehabilitation.&#xD;
  &#xD;
          Requires ventilator support Has an autoimmune etiology of spinal cord dysfunction/injury&#xD;
  &#xD;
          Has spasms that limit the ability to participate in the study training (as determined by&#xD;
          the Investigator)&#xD;
  &#xD;
          Has skin breakdown in area(s) that will come into contact with electrodes&#xD;
  &#xD;
          Has any active implanted medical device (e.g., cochlear implant, pacemaker, neurostimulator&#xD;
          or medication infusion device) Is pregnant, planning to become pregnant or currently&#xD;
          breastfeeding&#xD;
  &#xD;
          Has concurrent participation in another drug or device trial that may interfere with this&#xD;
          study&#xD;
  &#xD;
          Has other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal&#xD;
          injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response&#xD;
          to or participation in rehabilitation.&#xD;
  &#xD;
          Is not a candidate for other reason determined by the investigators&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.</citation>
      <PMID>26205686</PMID>
    </reference>
    <reference>
      <citation>Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.</citation>
      <PMID>36212800</PMID>
    </reference>
    <reference>
      <citation>Kumru H, Rodriguez-Canon M, Edgerton VR, Garcia L, Flores A, Soriano I, Opisso E, Gerasimenko Y, Navarro X, Garcia-Alias G, Vidal J. Transcutaneous Electrical Neuromodulation of the Cervical Spinal Cord Depends Both on the Stimulation Intensity and the Degree of Voluntary Activity for Training. A Pilot Study. J Clin Med. 2021 Jul 25;10(15):3278. doi: 10.3390/jcm10153278.</citation>
      <PMID>34362062</PMID>
    </reference>
    <reference>
      <citation>Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.</citation>
      <PMID>33192348</PMID>
    </reference>
    <reference>
      <citation>Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.</citation>
      <PMID>35160091</PMID>
    </reference>
    <reference>
      <citation>Capogrosso M, Wagner FB, Gandar J, Moraud EM, Wenger N, Milekovic T, Shkorbatova P, Pavlova N, Musienko P, Bezard E, Bloch J, Courtine G. Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Nat Protoc. 2018 Sep;13(9):2031-2061. doi: 10.1038/s41596-018-0030-9.</citation>
      <PMID>30190556</PMID>
    </reference>
    <reference>
      <citation>Wenger N, Moraud EM, Gandar J, Musienko P, Capogrosso M, Baud L, Le Goff CG, Barraud Q, Pavlova N, Dominici N, Minev IR, Asboth L, Hirsch A, Duis S, Kreider J, Mortera A, Haverbeck O, Kraus S, Schmitz F, DiGiovanna J, van den Brand R, Bloch J, Detemple P, Lacour SP, Bezard E, Micera S, Courtine G. Spatiotemporal neuromodulation therapies engaging muscle synergies improve motor control after spinal cord injury. Nat Med. 2016 Feb;22(2):138-45. doi: 10.1038/nm.4025. Epub 2016 Jan 18.</citation>
      <PMID>26779815</PMID>
    </reference>
    <reference>
      <citation>Najib U, Bashir S, Edwards D, Rotenberg A, Pascual-Leone A. Transcranial brain stimulation: clinical applications and future directions. Neurosurg Clin N Am. 2011 Apr;22(2):233-51, ix. doi: 10.1016/j.nec.2011.01.002.</citation>
      <PMID>21435574</PMID>
    </reference>
    <reference>
      <citation>Pascual-Leone A, Freitas C, Oberman L, Horvath JC, Halko M, Eldaief M, Bashir S, Vernet M, Shafi M, Westover B, Vahabzadeh-Hagh AM, Rotenberg A. Characterizing brain cortical plasticity and network dynamics across the age-span in health and disease with TMS-EEG and TMS-fMRI. Brain Topogr. 2011 Oct;24(3-4):302-15. doi: 10.1007/s10548-011-0196-8. Epub 2011 Aug 14.</citation>
      <PMID>21842407</PMID>
    </reference>
    <reference>
      <citation>Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.</citation>
      <PMID>19833552</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Thomas Jefferson University</investigator_affiliation>
      <investigator_full_name>Mijail Demian Serruya</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Spinal Cord Injuries</keyword>
    <keyword>Spinal Electrical Stimulation</keyword>
    <keyword>Transcutaneous Spinal Stimulation</keyword>
    <keyword>Transcutaneous Magnetic Simulation</keyword>
    <keyword>Transcranial Magnetic Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Spinal Cord Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994846
  org study id: Rises-T 2.0 iRISID-2023-2024
  nct id: NCT05994846
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The objectives of this study are to (1) determine the effects of neuromodulation techniques
        on mobility in persons with chronic SCI, as measured by subjective and objective measures,
        and (2) to determine the optimal combination of techniques that modify mobility and movement
        in an individual. The neuromodulation techniques explored will be methods of electromagnetic
        stimulation - that is, electrical stimulation and magnetic stimulation.
  The study is designed in two Parts. Part 1 of the study will collect information about the
        participant's baseline mobility and muscular activation potential. The information collected
        in these sessions will, in effect, assess the participant's eligibility to continue in the
        study and move onto Part 2.
  
        Part 1- Assessment Sessions This part of the study designed to determine (1) which, if any,
        of the participant's muscles respond to stimulation and, if there are responses observed, (2)
        what stimulation parameters and modalities would be best suited for the participant during
        Part 2 of the trial. The team will create a participant-specific menu of modalities and
        pre-defined parameters for electromagnetic stimulation (e.g., amplitude, channels,
        frequencies, electrode placement, etc.) from which they will select for participant visits in
        Part 2 of the study. They will also capture the participant's Movement Signature (the pattern
        of movement as measured by accelerometers and surface EMG that a person exhibits while
        sitting/standing at rest and/or doing specific tasks to inform Part 2 of the study. Finally,
        the participants will complete a Baseline Clinical Outcome Measures validated for SCI to
        provide baseline data prior to the neuromodulation intervention.
  
        Part 2 - The Experimental Cycles This part of the study will consist of Intervention
        Sessions, in which the team will apply transcutaneous stimulation to the participant's target
        muscles identified in Part 1, using the parameters and modalities deemed best suited for the
        participant. during tasks and activities deemed most appropriate for the targeted muscles.
        The team will measure the effects of electromagnetic stimulation on the participant's muscle
        activity and movement.
  
        The Cycle will also include Biometric sessions, where the participant will engage in a series
        of upper extremity, trunk and/or lower extremity repetitive tasks from their prescribed
        "activity library" that was created for them during Part 1 of the study and the team will
        measure changes in muscle tone, strength, and movement before and after stimulation. In other
        sessions, the participant will undergo a series of more targeted tasks with and without
        electromagnetic stimulation applied, to measure changes in the participant's neurophysiology,
        kinetics, and kinematics due to electromagnetic stimulation.
  
        After a series of Intervention and Biometrics Sessions, if there are no changes observed in
        the participant's kinematics or EMG signals in the and/or in select outcome measures, the
        participant will enter a Parameter Optimization Session. During this session, the study team
        will revisit the library of stimulation parameters that were defined for the participant
        during Part 1 of the study and refine the parameters for use in the next Experimental Cycle.
        The manipulation and refinement of these parameters will be done with the aim of achieving
        changes in the subsequent Experimental Cycle.
  
        The participant will continue in the study until the time that there is no observed effect of
        stimulation for three (3) consecutive Experimental Cycles, or may continue for a maximum of
        six (6) Experimental Cycles. At the end of the study, the participant will repeat the series
        of Clinical Outcome Measures that were completed at Baseline.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective, unblinded, feasibility study where participants will serve as their own controls.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Spinal Cord Injury-Motor Index (SCI MovIN)
  time frame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
  description: evaluates movement, and recovery of neurotypical movement, within a functional context that accounts for compensations and disallows substitutions
  measure: Modified Ashworth Scale (MAS)
  time frame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
  description: measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone
  measure: Manual Muscle Testing (MMT)
  time frame: Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks
  description: standardized set of assessments that measure muscle strength and function
  measure: Capabilities of Upper Extremity Test (CUE-T)
  time frame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
  description: A performance measure intended to assess upper extremity function following spinal cord injury (SCI)
  measure: PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)
  time frame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
  description: A patient self-reported measure of consequences of pain on aspects of their life
  measure: Walking Index for SCI (WISCI-II)
  time frame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
  description: A measure of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI
  measure: Numeric Pain Rating Scale (NPRS)
  time frame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
  description: The patient reported outcome measure the subjective intensity of pain
  measure: Patient Global Impression of Change (PGIC) Questionnaires (bowel program, bladder function, dysreflexia, pain, sensation)
  time frame: Once at 2 weeks after consent, and once within 9-24 weeks after consent
  description: Questionnaires to assess the status of or changes in bladder function, bowel regimen, dysreflexia, pain and sensation.
  arm group label: Experimental Treatment Arm
  arm group type: Experimental
  description: Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice
  intervention type: Device
  intervention name: RISES-T System
  description: The RISES-T system is a hardware and software platform that has been designed and developed to help people living with movement impairment due to Spinal Cord Injury (SCI) to improve and/or restore mobility. The hardware consists of a functional electrical stimulation device that delivers stimulation to the skin through surface electrodes; a series of wearable sensors that collect kinematic (IMU) data and muscle activity (EMG) data, and RISES Software, which incorporates algorithms that utilizes the streaming IMU and EMG sensor data to inform the electrical stimulation parameters and enables real-time visualization of the sensor data and stimulation parameters via Graphical User Interface (GUI).
  arm group label: Experimental Treatment Arm
  other name: Trancutaneous spinal stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  citation: Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
  PMID: 26205686
  citation: Manson G, Atkinson DA, Shi Z, Sheynin J, Karmonik C, Markley RL, Sayenko DG. Transcutaneous spinal stimulation alters cortical and subcortical activation patterns during mimicked-standing: A proof-of-concept fMRI study. Neuroimage Rep. 2022 Jun;2(2):100090. doi: 10.1016/j.ynirp.2022.100090. Epub 2022 Mar 8.
  PMID: 36212800
  citation: Kumru H, Rodriguez-Canon M, Edgerton VR, Garcia L, Flores A, Soriano I, Opisso E, Gerasimenko Y, Navarro X, Garcia-Alias G, Vidal J. Transcutaneous Electrical Neuromodulation of the Cervical Spinal Cord Depends Both on the Stimulation Intensity and the Degree of Voluntary Activity for Training. A Pilot Study. J Clin Med. 2021 Jul 25;10(15):3278. doi: 10.3390/jcm10153278.
  PMID: 34362062
  citation: Rejc E, Smith AC, Weber KA 2nd, Ugiliweneza B, Bert RJ, Negahdar M, Boakye M, Harkema SJ, Angeli CA. Spinal Cord Imaging Markers and Recovery of Volitional Leg Movement With Spinal Cord Epidural Stimulation in Individuals With Clinically Motor Complete Spinal Cord Injury. Front Syst Neurosci. 2020 Oct 21;14:559313. doi: 10.3389/fnsys.2020.559313. eCollection 2020.
  PMID: 33192348
  citation: Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
  PMID: 35160091
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  responsible party type: Principal Investigator
  investigator affiliation: Thomas Jefferson University
  investigator full name: Mijail Demian Serruya
  investigator title: Associate Professor
  mesh term: Spinal Cord Injuries
  mesh term: Spinal Cord Diseases
  sharing ipd: No