<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/NCT02970006</url>
  </required_header>
  <id_info>
    <org_study_id>2016H0202</org_study_id>
    <nct_id>NCT02970006</nct_id>
  </id_info>
  <brief_title>Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion</brief_title>
  <official_title>Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg&#xD;
      illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a&#xD;
      custom-designed virtual reality leg scenario) will lead to controlled analgesia induction,&#xD;
      boosting analgesic effects obtained with standard SCS treatments and will further be&#xD;
      associated with changes in the perception of the affected body part.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidural spinal cord stimulation (SCS) is an approved treatment for truncal and extremity&#xD;
      neuropathic pain. The mechanisms underlying the efficacy of SCS are unknown. Recent advances&#xD;
      in cognitive neuroprosthetics using virtual reality allow for modulation of body perception&#xD;
      and bodily experience, which has also been shown to modulate pain perception. The present&#xD;
      research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation&#xD;
      techniques in order to test the analgesic properties of the combination of epidural spinal&#xD;
      cord stimulation with a new system of multisensory stimulation based on virtual and enhanced&#xD;
      reality (i.e., neuro-visual stimulation). The investigators propose to study this hypothesis&#xD;
      prospectively in 25 patients with implanted SCS systems for the treatment of chronic&#xD;
      neuropathic pain. Primary outcomes will be pain reduction (based on subjective, functional&#xD;
      and physiological measures) and changes in body perception (based on subjective and objective&#xD;
      measures). The present study will generate a proof-of-concept for the application of&#xD;
      neuro-visual stimulation for the treatment of chronic pain and will form the basis for future&#xD;
      NIH funding application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Pain Reduction Post Intervention</measure>
    <time_frame>At each hour from 1-5 hours post intervention</time_frame>
    <description>10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from &quot;no pain&quot; (bottom part of the scale) to &quot;the worst imaginable pain&quot; (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Reduction Base on Patient Perception</measure>
    <time_frame>per minute in each virtual reality condition for 10 minutes in each reality condition.</time_frame>
    <description>Validated questionnaires developed by the collaborators (Swiss Federal Institute of Technology) will be used in order to investigate induced changes in leg perception and ownership. In particular, we will assess: 1) feeling of ownership towards the leg shown in the virtual reality set-up (leg ownership); 2) tactile sensations felt on the virtual legs, depending on the different conditions of SCS and visual stimulation. Patients will be asked to indicate how much they agreed with each item using a 7-point colored vertical Likert scale ranging from 0 (complete disagreement, the bottom extreme, red point) to +6 (complete agreement, the top extreme, green point).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Neuropathy;Peripheral</condition>
  <arm_group>
    <arm_group_label>neurovisual stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>neurovisual stimulation</intervention_name>
    <description>a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
    <arm_group_label>neurovisual stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-and older at the time of enrollment&#xD;
&#xD;
          2. Patients carrying a diagnosis of CPRS type 125 or chronic refractory neuropathic leg&#xD;
             pain following FBS4&#xD;
&#xD;
          3. Patients who have implanted epidural SCS&#xD;
&#xD;
          4. The SCS implantation for at least three months prior to enrollment&#xD;
&#xD;
          5. Patients with efficacious SCS as defined by ≥ 50% pain improvement after switching SCS&#xD;
             from an OFF state to an ON state ('optimal' stimulation efficacy)&#xD;
&#xD;
          6. Patients willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are unable to effectively or efficiently communicate for example patients&#xD;
             suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.&#xD;
&#xD;
          2. Patients with history of prior cranial surgery, significant brain lesions for example&#xD;
             intracranial tumors, strokes etc.&#xD;
&#xD;
          3. Non efficacious response to SCS &lt;50% pain improvement with optimal stimulation&#xD;
             parameters&#xD;
&#xD;
          4. Evidence of untreated psychiatric disorders or drugs/alcohol abuse.&#xD;
&#xD;
          5. History of seizures&#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>Vibhor R Krishna, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio Sate University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>December 3, 2019</results_first_submitted>
  <results_first_submitted_qc>August 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2021</results_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Vibhor Krishna</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>spinal cord stimulation</keyword>
  <keyword>virtual reality</keyword>
  <keyword>full body illusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Illusions</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02970006/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Neurovisual Stimulation</title>
          <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.&#xD;
neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Neurovisual Stimulation</title>
          <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.&#xD;
neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.7" spread="9.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Pain Reduction Post Intervention</title>
        <description>10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from &quot;no pain&quot; (bottom part of the scale) to &quot;the worst imaginable pain&quot; (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.</description>
        <time_frame>At each hour from 1-5 hours post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Neurovisual Stimulation</title>
            <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.&#xD;
neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Reduction Post Intervention</title>
          <description>10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from &quot;no pain&quot; (bottom part of the scale) to &quot;the worst imaginable pain&quot; (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Reduction Base on Patient Perception</title>
        <description>Validated questionnaires developed by the collaborators (Swiss Federal Institute of Technology) will be used in order to investigate induced changes in leg perception and ownership. In particular, we will assess: 1) feeling of ownership towards the leg shown in the virtual reality set-up (leg ownership); 2) tactile sensations felt on the virtual legs, depending on the different conditions of SCS and visual stimulation. Patients will be asked to indicate how much they agreed with each item using a 7-point colored vertical Likert scale ranging from 0 (complete disagreement, the bottom extreme, red point) to +6 (complete agreement, the top extreme, green point).</description>
        <time_frame>per minute in each virtual reality condition for 10 minutes in each reality condition.</time_frame>
        <population>Patients will rate their pain reduction on a scale of 0-6, each minute in each of the three virtual reality conditions. The pain score change reported is an average of all time points in all virtual reality settings. A change in pain rating was calculated between different SCS and VR conditions. Percentage pain reduction was then calculated to test whether SCS combined with VR reduced pain more significantly than VR alone. The calculation done was a mean score of all pain ratings at all points.</population>
        <group_list>
          <group group_id="O1">
            <title>Neurovisual Stimulation</title>
            <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.&#xD;
neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Reduction Base on Patient Perception</title>
          <description>Validated questionnaires developed by the collaborators (Swiss Federal Institute of Technology) will be used in order to investigate induced changes in leg perception and ownership. In particular, we will assess: 1) feeling of ownership towards the leg shown in the virtual reality set-up (leg ownership); 2) tactile sensations felt on the virtual legs, depending on the different conditions of SCS and visual stimulation. Patients will be asked to indicate how much they agreed with each item using a 7-point colored vertical Likert scale ranging from 0 (complete disagreement, the bottom extreme, red point) to +6 (complete agreement, the top extreme, green point).</description>
          <population>Patients will rate their pain reduction on a scale of 0-6, each minute in each of the three virtual reality conditions. The pain score change reported is an average of all time points in all virtual reality settings. A change in pain rating was calculated between different SCS and VR conditions. Percentage pain reduction was then calculated to test whether SCS combined with VR reduced pain more significantly than VR alone. The calculation done was a mean score of all pain ratings at all points.</population>
          <units>average score on scale of pain reduction</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The experiment included 2 sessions occurring at 24 hours interval, the first session was used for clinical assessment and the personalization of the visual illumination administered in the virtual environment, while the experimental protocol was performed the second day. The duration of each session was between 90-120 minutes. Adverse events were monitored over that time.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Neurovisual Stimulation</title>
          <description>Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.&#xD;
neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vibhor Krishna, MD</name_or_title>
      <organization>The Ohio State University- Neurological Institute</organization>
      <phone>6142939274</phone>
      <email>Vibhor.Krishna@osumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02970006
org study id: 2016H0202
nct id: NCT02970006
lead sponsor: 
collaborator: 
has dmc: No
The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg
      illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a
      custom-designed virtual reality leg scenario) will lead to controlled analgesia induction,
      boosting analgesic effects obtained with standard SCS treatments and will further be
      associated with changes in the perception of the affected body part.
Epidural spinal cord stimulation (SCS) is an approved treatment for truncal and extremity
      neuropathic pain. The mechanisms underlying the efficacy of SCS are unknown. Recent advances
      in cognitive neuroprosthetics using virtual reality allow for modulation of body perception
      and bodily experience, which has also been shown to modulate pain perception. The present
      research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation
      techniques in order to test the analgesic properties of the combination of epidural spinal
      cord stimulation with a new system of multisensory stimulation based on virtual and enhanced
      reality (i.e., neuro-visual stimulation). The investigators propose to study this hypothesis
      prospectively in 25 patients with implanted SCS systems for the treatment of chronic
      neuropathic pain. Primary outcomes will be pain reduction (based on subjective, functional
      and physiological measures) and changes in body perception (based on subjective and objective
      measures). The present study will generate a proof-of-concept for the application of
      neuro-visual stimulation for the treatment of chronic pain and will form the basis for future
      NIH funding application.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Average Pain Reduction Post Intervention
time frame: At each hour from 1-5 hours post intervention
description: 10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from "no pain" (bottom part of the scale) to "the worst imaginable pain" (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.
measure: Pain Reduction Base on Patient Perception
time frame: per minute in each virtual reality condition for 10 minutes in each reality condition.
description: Validated questionnaires developed by the collaborators (Swiss Federal Institute of Technology) will be used in order to investigate induced changes in leg perception and ownership. In particular, we will assess: 1) feeling of ownership towards the leg shown in the virtual reality set-up (leg ownership); 2) tactile sensations felt on the virtual legs, depending on the different conditions of SCS and visual stimulation. Patients will be asked to indicate how much they agreed with each item using a 7-point colored vertical Likert scale ranging from 0 (complete disagreement, the bottom extreme, red point) to +6 (complete agreement, the top extreme, green point).
arm group label: neurovisual stimulation
arm group type: Experimental
description: Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.
intervention type: Device
intervention name: neurovisual stimulation
description: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)
arm group label: neurovisual stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vibhor R Krishna, MBBS
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Vibhor Krishna
investigator title: Assistant Clinical Professor
mesh term: Illusions
mesh term: Peripheral Nervous System Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 