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Trial record 1 of 1 for:    NCT04418362
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Axon - Brain Train for Pain

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ClinicalTrials.gov Identifier: NCT04418362
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
East Midlands Spine Ltd
PhysioFunction Ltd
Information provided by (Responsible Party):
Exsurgo Rehab Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Depression, Anxiety Sleep Quality of Life Other: Neurofeedback training Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Neurofeedback training
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.
Other: Neurofeedback training
A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.




Primary Outcome Measures :
  1. 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 ]
    Ordinal measurement of individual's pain intensity


Secondary Outcome Measures :
  1. 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 ]
    Rating scale (self-administered)

  2. 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 ]
    A self-report questionnaire assessing sleep quality

  3. 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 ]
    A self-assessed, health related, quality of life questionnaire.

  4. Changes in EEG activity [ Time Frame: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks ]
    Changes in relative Alpha, Theta and Beta ratio, as measured by EEG

  5. Experience of chronic pain and neurofeedback training [ Time Frame: Post-intervention - after final training session (8 weeks) ]
    Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Head circumference range (560 - 595 mm)
  • Patients suffering from chronic pain (mean VNS >4) for at least 6 months.
  • Chronic pain from any neurological or musculoskeletal cause, of which examples could be, post herpetic (or post-shingles) neuralgia, complex regional pain syndrome (CRPS), lower back pain, neck pain, major joint pain, spinal cord injury, phantom limb pain, brachial plexus injury related pain, traumatic peripheral nerve injury pain and post-cancer treatment pain
  • Stable medication and treatment over the intervention period
  • Participant or caregiver with minimum computer literacy able to effectively operate equipment after training, and the ability to position and remove headset effectively for training sessions

Exclusion Criteria:

  • Patients who do not meet inclusion criteria (above)
  • Failing pre-screening suitability criteria for neurofeedback due to a neurological disorder, psychiatric disorder, epilepsy, regular use of benzodiazepines, previous neurofeedback training, serious head injury and other medication that has contraindications for neurofeedback training
  • Dreadlocks, braids, beads, or any other hairstyle or hair covering that cannot be removed for training
  • Known or suspected pregnancy
  • Diagnosis of (or currently undergoing treatment for) cancer, systemic infection, severe cardiovascular/respiratory comorbidity
  • Implanted electronic neuromodulation device
  • Implanted pacemaker or loop recorder
  • Any change in medication or treatment planned during the intervention period
  • Inability to use the equipment due to severity of pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418362


Contacts
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Contact: Christine Ozolins +447735 572017 christine@exsurgorehab.com
Contact: Richard Little richard.little@exsurgorehab.com

Locations
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United Kingdom
East Midlands Spine Ltd Recruiting
Northampton, United Kingdom
Contact: Nicholas Birch         
Contact: Jon Graham         
Sponsors and Collaborators
Exsurgo Rehab Limited
East Midlands Spine Ltd
PhysioFunction Ltd
Investigators
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Principal Investigator: Nicholas Birch East Midlands Spine Ltd
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Responsible Party: Exsurgo Rehab Limited
ClinicalTrials.gov Identifier: NCT04418362    
Other Study ID Numbers: ED1001033
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations