<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/NCT04418362</url>
  </required_header>
  <id_info>
    <org_study_id>ED1001033</org_study_id>
    <nct_id>NCT04418362</nct_id>
  </id_info>
  <brief_title>Axon - Brain Train for Pain</brief_title>
  <official_title>Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exsurgo Rehab Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>East Midlands Spine Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PhysioFunction Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Exsurgo Rehab Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A mixed methods proof of concept study to ascertain the effectiveness of a home-based&#xD;
      self-administered neurofeedback intervention to treat the primary and secondary symptoms of&#xD;
      chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to address the growing problem of chronic pain management in the UK, a proof of&#xD;
      concept/feasibility open label study has been devised to test a home-based self-administered&#xD;
      non-pharmacological treatment utilising neurofeedback training with a headset and&#xD;
      tablet-based software application.&#xD;
&#xD;
      This study will include individuals suffering from various types of chronic pain, measuring&#xD;
      changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and&#xD;
      quality of life) by utilising a purpose-built software application and headset that is easy&#xD;
      to use and structurally robust.&#xD;
&#xD;
      Twenty participants will take part in pre-intervention quantitative assessments measuring the&#xD;
      primary and secondary symptoms of chronic pain. This will be followed by one-to-one remote&#xD;
      training where they will be provided with detailed instructions on how to self-administer the&#xD;
      neurofeedback training in the comfort of their own homes. They will then take part in 4-6&#xD;
      training sessions per week over an 8-week period.&#xD;
&#xD;
      Post- intervention quantitative assessments will be conducted alongside a qualitative&#xD;
      analysis of the experience of doing neurofeedback training for chronic pain. Participant&#xD;
      feedback on how the protocol, equipment and research could be improved will also be recorded&#xD;
      to inform further research.&#xD;
&#xD;
      Participants will also take part in online follow-up assessments at 1, 3, and 6 months after&#xD;
      the intervention. Any adjustments to pain medication will also be recorded over this period.&#xD;
      It is anticipated this study will provide initial evidence of the safety, efficacy,&#xD;
      reliability and validity of a low-cost non-pharmacological solution to the physical,&#xD;
      psychological and social difficulties experienced by individuals with chronic pain, with a&#xD;
      view to a larger subsequent multisite trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">July 28, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Single group assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity as measured by the VNS (Visual Numerical Scale)</measure>
    <time_frame>Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session</time_frame>
    <description>Ordinal measurement of individual's pain intensity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session</time_frame>
    <description>Rating scale (self-administered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session</time_frame>
    <description>A self-report questionnaire assessing sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life components as measured by the EQ-5D-5L</measure>
    <time_frame>Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session</time_frame>
    <description>A self-assessed, health related, quality of life questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in EEG activity</measure>
    <time_frame>Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks</time_frame>
    <description>Changes in relative Alpha, Theta and Beta ratio, as measured by EEG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience of chronic pain and neurofeedback training</measure>
    <time_frame>Post-intervention - after final training session (8 weeks)</time_frame>
    <description>Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Depression, Anxiety</condition>
  <condition>Sleep</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Neurofeedback training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neurofeedback training: self-administered at home 4-6 times per week for 8 weeks. Each session consists of 6 blocks of 5 minute training with a one minute rest period between each block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurofeedback training</intervention_name>
    <description>A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.</description>
    <arm_group_label>Neurofeedback training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Head circumference range (560 - 595 mm)&#xD;
&#xD;
          -  Patients suffering from chronic pain (mean VNS &gt;4) for at least 6 months.&#xD;
&#xD;
          -  Chronic pain from any neurological or musculoskeletal cause, of which examples could&#xD;
             be, post herpetic (or post-shingles) neuralgia, complex regional pain syndrome (CRPS),&#xD;
             lower back pain, neck pain, major joint pain, spinal cord injury, phantom limb pain,&#xD;
             brachial plexus injury related pain, traumatic peripheral nerve injury pain and&#xD;
             post-cancer treatment pain&#xD;
&#xD;
          -  Stable medication and treatment over the intervention period&#xD;
&#xD;
          -  Participant or caregiver with minimum computer literacy able to effectively operate&#xD;
             equipment after training, and the ability to position and remove headset effectively&#xD;
             for training sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet inclusion criteria (above)&#xD;
&#xD;
          -  Failing pre-screening suitability criteria for neurofeedback due to a neurological&#xD;
             disorder, psychiatric disorder, epilepsy, regular use of benzodiazepines, previous&#xD;
             neurofeedback training, serious head injury and other medication that has&#xD;
             contraindications for neurofeedback training&#xD;
&#xD;
          -  Dreadlocks, braids, beads, or any other hairstyle or hair covering that cannot be&#xD;
             removed for training&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Diagnosis of (or currently undergoing treatment for) cancer, systemic infection,&#xD;
             severe cardiovascular/respiratory comorbidity&#xD;
&#xD;
          -  Implanted electronic neuromodulation device&#xD;
&#xD;
          -  Implanted pacemaker or loop recorder&#xD;
&#xD;
          -  Any change in medication or treatment planned during the intervention period&#xD;
&#xD;
          -  Inability to use the equipment due to severity of pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas Birch</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Midlands Spine Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>East Midlands Spine Ltd</name>
      <address>
        <city>Northampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</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/NCT04418362
org study id: ED1001033
nct id: NCT04418362
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A mixed methods proof of concept study to ascertain the effectiveness of a home-based
      self-administered neurofeedback intervention to treat the primary and secondary symptoms of
      chronic pain.
In order to address the growing problem of chronic pain management in the UK, a proof of
      concept/feasibility open label study has been devised to test a home-based self-administered
      non-pharmacological treatment utilising neurofeedback training with a headset and
      tablet-based software application.

      This study will include individuals suffering from various types of chronic pain, measuring
      changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and
      quality of life) by utilising a purpose-built software application and headset that is easy
      to use and structurally robust.

      Twenty participants will take part in pre-intervention quantitative assessments measuring the
      primary and secondary symptoms of chronic pain. This will be followed by one-to-one remote
      training where they will be provided with detailed instructions on how to self-administer the
      neurofeedback training in the comfort of their own homes. They will then take part in 4-6
      training sessions per week over an 8-week period.

      Post- intervention quantitative assessments will be conducted alongside a qualitative
      analysis of the experience of doing neurofeedback training for chronic pain. Participant
      feedback on how the protocol, equipment and research could be improved will also be recorded
      to inform further research.

      Participants will also take part in online follow-up assessments at 1, 3, and 6 months after
      the intervention. Any adjustments to pain medication will also be recorded over this period.
      It is anticipated this study will provide initial evidence of the safety, efficacy,
      reliability and validity of a low-cost non-pharmacological solution to the physical,
      psychological and social difficulties experienced by individuals with chronic pain, with a
      view to a larger subsequent multisite trial.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pain intensity as measured by the VNS (Visual Numerical Scale)
time frame: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
description: Ordinal measurement of individual's pain intensity
measure: Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
description: Rating scale (self-administered)
measure: Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
description: A self-report questionnaire assessing sleep quality
measure: Change in quality of life components as measured by the EQ-5D-5L
time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
description: A self-assessed, health related, quality of life questionnaire.
measure: Changes in EEG activity
time frame: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
description: Changes in relative Alpha, Theta and Beta ratio, as measured by EEG
measure: Experience of chronic pain and neurofeedback training
time frame: Post-intervention - after final training session (8 weeks)
description: Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain
arm group label: Neurofeedback training
arm group type: Experimental
description: Neurofeedback training: self-administered at home 4-6 times per week for 8 weeks. Each session consists of 6 blocks of 5 minute training with a one minute rest period between each block.
intervention type: Other
intervention name: Neurofeedback training
description: A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
arm group label: Neurofeedback training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nicholas Birch
role: Principal Investigator
affiliation: East Midlands Spine Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No