<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/NCT02237885</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00068864</org_study_id>
    <secondary_id>R34AT008399-01</secondary_id>
    <secondary_id>14-1138</secondary_id>
    <secondary_id>Pro00068864</secondary_id>
    <nct_id>NCT02237885</nct_id>
  </id_info>
  <brief_title>Pain Management Using Mobile Technology in Veterans With PTSD and TBI</brief_title>
  <official_title>Pain Management Using Mobile Technology in Veterans With PTSD and TBI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to half of military veterans with traumatic brain injury (TBI) also suffer from&#xD;
      co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic&#xD;
      pain, one of the most common health complaints among U.S. veterans who served in Operation&#xD;
      Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn&#xD;
      (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate&#xD;
      that veterans perceive barriers to traditional mental health treatments. Little research&#xD;
      exists regarding non-pharmacological, technology-based interventions designed to reduce pain&#xD;
      in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG&#xD;
      biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain&#xD;
      in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of&#xD;
      using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI.&#xD;
      Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG&#xD;
      brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides&#xD;
      neurofeedback to induce relaxation). Veterans are taught how to use these together to do&#xD;
      neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary&#xD;
      data, we hypothesize that participants will show high levels of adherence to the NeuroSky +&#xD;
      Mobile Neurofeedback intervention for the 3-month study duration and that participants will&#xD;
      show statistically significant reduction in pain symptoms at 3 months compared to baseline.&#xD;
      Given links between pain and other outcomes in veterans, we will also explore effects on drug&#xD;
      abuse, violence, and suicidality. When the research is complete, the field will be changed&#xD;
      because we will know whether new technology reading EEG brainwaves can be used to treat&#xD;
      symptoms among individuals suffering from chronic pain. We will also know whether&#xD;
      neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to&#xD;
      reduce pain and related outcomes. If this program of research is successful, its impact will&#xD;
      be to shift approaches to managing pain in clinical practice, for both veterans and civilians&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">November 21, 2017</completion_date>
  <primary_completion_date type="Actual">November 21, 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of ten minute neurofeedback sessions completed on mobile platform</measure>
    <time_frame>3 months</time_frame>
    <description>Per protocol, participants will be requested to complete 4 neurofeedback sessions per week for 12 weeks. This data will be collected on participants' mobile devices.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Per protocol, participants are enrolled if they have chronic pain defined as self-reporting on the numeric rating scale a score of 4 or above lasting three months or more. The study will therefore ask participants to self report their level of pain (from 0-10, 0 least amount of pain, 10 being the most) following the three months of the neurofeedback sessions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Posttraumatic Stress Disorders</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuroSky MindWave Mobile</intervention_name>
    <arm_group_label>Neurofeedback</arm_group_label>
    <other_name>Mobile Neurofeedback (Application)</other_name>
    <other_name>Apple iPod touch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Military veteran who served during Operation Enduring Freedom (OEF), Operation Iraqi&#xD;
             Freedom (OIF), and/or Operation New Dawn (OND)&#xD;
&#xD;
          -  Posttraumatic Stress Disorder (PTSD)&#xD;
&#xD;
          -  Traumatic Brain Injury (TBI)&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of epilepsy, seizure disorder, or have ever had a seizure or epileptic fit&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#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>Eric Elbogen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University, Dept. of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University, Department of Psychiatry</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Elbogen EB, Alsobrooks A, Battles S, Molloy K, Dennis PA, Beckham JC, McLean SA, Keith JR, Russoniello C. Mobile Neurofeedback for Pain Management in Veterans with TBI and PTSD. Pain Med. 2021 Feb 23;22(2):329-337. doi: 10.1093/pm/pnz269.</citation>
    <PMID>31697371</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Military Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <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/NCT02237885
org study id: Pro00068864
secondary id: R34AT008399-01
secondary id: 14-1138
secondary id: Pro00068864
nct id: NCT02237885
lead sponsor: 
collaborator: 
has dmc: Yes
Up to half of military veterans with traumatic brain injury (TBI) also suffer from
      co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic
      pain, one of the most common health complaints among U.S. veterans who served in Operation
      Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn
      (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate
      that veterans perceive barriers to traditional mental health treatments. Little research
      exists regarding non-pharmacological, technology-based interventions designed to reduce pain
      in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG
      biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain
      in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of
      using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI.
      Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG
      brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides
      neurofeedback to induce relaxation). Veterans are taught how to use these together to do
      neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary
      data, we hypothesize that participants will show high levels of adherence to the NeuroSky +
      Mobile Neurofeedback intervention for the 3-month study duration and that participants will
      show statistically significant reduction in pain symptoms at 3 months compared to baseline.
      Given links between pain and other outcomes in veterans, we will also explore effects on drug
      abuse, violence, and suicidality. When the research is complete, the field will be changed
      because we will know whether new technology reading EEG brainwaves can be used to treat
      symptoms among individuals suffering from chronic pain. We will also know whether
      neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to
      reduce pain and related outcomes. If this program of research is successful, its impact will
      be to shift approaches to managing pain in clinical practice, for both veterans and civilians
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Number of ten minute neurofeedback sessions completed on mobile platform
time frame: 3 months
description: Per protocol, participants will be requested to complete 4 neurofeedback sessions per week for 12 weeks. This data will be collected on participants' mobile devices.
measure: Change in participant's self-reported pain score from 0-10, 0 least amount of pain, 10 highest
time frame: Baseline, 3 months
description: Per protocol, participants are enrolled if they have chronic pain defined as self-reporting on the numeric rating scale a score of 4 or above lasting three months or more. The study will therefore ask participants to self report their level of pain (from 0-10, 0 least amount of pain, 10 being the most) following the three months of the neurofeedback sessions.
arm group label: Neurofeedback
arm group type: Experimental
intervention type: Device
intervention name: NeuroSky MindWave Mobile
arm group label: Neurofeedback
other name: Mobile Neurofeedback (Application)
other name: Apple iPod touch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Elbogen, PhD
role: Principal Investigator
affiliation: Duke University, Dept. of Psychiatry
facility: 
country: United States
citation: Elbogen EB, Alsobrooks A, Battles S, Molloy K, Dennis PA, Beckham JC, McLean SA, Keith JR, Russoniello C. Mobile Neurofeedback for Pain Management in Veterans with TBI and PTSD. Pain Med. 2021 Feb 23;22(2):329-337. doi: 10.1093/pm/pnz269.
PMID: 31697371
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Chronic Pain
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No