Axon - Brain Train for Pain

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Exsurgo Rehab Limited
Updated on 5 August 2020
psychiatric disorder
cancer
benzodiazepines
neuromodulation
arthralgia
back pain
spinal cord
neck pain
chronic pain
epilepsy
neuralgia
systemic infection
pain disorder
mental illness
neurofeedback
complex regional pain syndrome
low back pain
limb pain
change in medication
peripheral nerve injury
brachial plexus injury

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.

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.

Details
Condition Pain, Pain, Quality of life, Sleep, Chronic Pain, Chronic Pain, Depression, Anxiety
Age 18years - 65years
Treatment Neurofeedback training
Clinical Study IdentifierNCT04418362
SponsorExsurgo Rehab Limited
Last Modified on5 August 2020

Eligibility

Yes No Not Sure

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
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