Axon - Brain Train for Pain
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|ClinicalTrials.gov Identifier: NCT04418362|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Depression, Anxiety Sleep Quality of Life||Other: Neurofeedback training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group assignment|
|Masking:||None (Open Label)|
|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 :||January 31, 2021|
|Estimated Study Completion Date :||February 28, 2021|
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.
- 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
- 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)
- 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
- 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.
- 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
- 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
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
|East Midlands Spine Ltd|
|Northampton, United Kingdom|
|Principal Investigator:||Nicholas Birch||East Midlands Spine Ltd|